Generated HTML representation of the validation rules processed
by the Schematron engine.
The validation rules are used to validate the data a Clinical Trial Application XML against above defined set of rules.
| Rule ID | CT Section
|
Field Description | Rule Description |
|---|---|---|---|
|
Generated HTML representation of the validation rules processed
by the Schematron engine. |
|||
| FEAT6.2.1.02 | D. IMP Identification | D. IMP Identification | There should always be at least one IMP. |
| FEAT6.2.1.02 | D. IMP Identification | D. IMP Identification | There should always be at least one IMP. |
| FEAT6.2.2.01 | A. Trial Identification | A.6 Resubmission letter | The question "Is this a resubmission? Should always be answered "Yes" or "No". If the answer is "No" the entry from the drop-down list should be "First Submission" if the answer is "Yes" the entry should be Resubmission A or B or further letters in the list. |
| FEAT6.2.4 | A. Trial Identification | A.1 National Competent Authority | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.2 EudraCT Number | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.3 Full title of the trial | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.4.1 Sponsor's protocol code number | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.4.3 Sponsor's protocol date yyyy-mm-dd | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.6 Is this a resubmission? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.6 Indicate the resubmission letter or else select 'First submission' | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | A. Trial Identification | A.7 Is the trial part of an agreed Paediatric Investigation Plan? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.26 | B.2 Legal Representative | B.1.3.4 Country | The 'B.2 Legal Representative' section should only be completed when 'B.1.3.4 Country' is not a member state. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.1 Name of organisation | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.2.1 Given name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.2.3 Family name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.3.1 Street Address | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.3.2 Town/ city | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.3.3 Post code | Complete if known. |
| FEAT6.2.4 | B.2 Legal Representative | B.2.3.4 Country | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.03 | B.2 Legal Representative | B.2.4 Telephone number/B.2.5 Fax number/B.2.6 E-mail | You should provide either a telephone number or fax number or email address for the legal representative of the trial. |
| FEAT6.2.1.44 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.4 Telephone number/B.5.5 Fax number/B.5.6 E-mail | You should provide either a telephone number or email address for the contact point designated by the sponsor for further information on the trial. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.1 Name of organisation | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.2.1 Given name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.2.3 Family name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.3.1 Street Address | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.3.2 Town/ city | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.3.3 Post code | Complete if known. |
| FEAT6.2.4 | B.1 Sponsor Organisation | B.1.3.4 Country | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.01 | B.1 Sponsor Organisation | B.1.4 Telephone number/B.1.5 Fax number/B.1.6 E-mail | You should provide either a telephone number or fax number or email address for the sponsor organisation information on the trial. |
| FEAT6.2.4 | B.3.1 and B.3.2 Status of the sponsor | B.3.1 and B.3.2 Status of the sponsor | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.4 Source(s) of Monetary or Material Support for the clinical trial (repeat as necessary) | B.4.1 Name of organisation | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.4 Source(s) of Monetary or Material Support for the clinical trial (repeat as necessary) | B.4.2 Country | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.1 Name of organisation | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.2 Functional name of contact point | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.3.1 Street Address | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.3.2 Town/ city | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.3.3 Post code | Complete if known. |
| FEAT6.2.4 | B.5 Contact point designated by the sponsor for further information on the trial | B.5.3.4 Country | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.04 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.4/C.1.4.5/C.1.4.6 Applicant Telephone/Fax/Email | At least one of 'C.1.4.4 CA Telephone number', 'C.1.4.5 CA Applicant Fax', and 'C.1.4.6 CA Applicant Email' must be completed |
| FEAT6.2.2.05a | C.1 Applicant Identification - Request for the Competent Authority | C.1.5 Request to receive a copy of the CTA data as XML | If 'C.1.5.1 Do you want a copy of this data saved on EudraCT as an XML File?' is 'Yes' then 'C.1.5.1.1 E-mail' should contain at least one email address and 'C.1.5.1.2 Secure E-mail (EudraLink account)?' must be completed. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.1 and C.1.2 and C.1.3 | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.1 Name of Organisation | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.2.1 Given Name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.2.3 Family name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.3.1 Street address | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.3.2 Town/ city | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.4.3.4 Country | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | C.1 Applicant Identification - Request for the Competent Authority | C.1.5.1 Do you want a copy of the CTA form data saved on EudraCT as an XML file? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.06 | C.2 Applicant Identification - Request for the Ethics Committee | C.2 Request for Opinion of the Ethics Committee | This section is not mandatory. It should be completed for applications to ethics committees in those Member States where the Ethics Committee requests this form as part of the application to them. If completed then all fields mandatory except 'C.2.5.2.1 Given Name' and 'C.2.5.2.2 Middle name'. |
| FEAT6.2.2.7b | D.1/D.2 IMP Identification and Status Details | D.2.1 Has the IMP to be used in the trial a marketing authorisation | If 'D.2.1 IMP has MA' is 'Yes' and all D.2.2 subsections are answered as 'No', then all D.2.1.1.1, D.2.1.1.2, D.2.1.1.3 and D.2.1.2 must be answered. |
| FEAT6.2.2.7a | D.1/D.2 IMP Identification and Status Details | D.2.1 Has the IMP to be used in the trial a marketing authorisation | If 'D.2.1 IMP has MA' is answered "No" the applicant should then go to D.2.3, and need not answer further questions in D.2.1 or D.2.2. Regarding autofill in of the member state and setting D.2.1.2.1 = Yes, If the IMP does not have a marketing authorisation which is the default setting, please remove the country and set D.2.1.2.1 = No to avoid the validation rule error. |
| FEAT6.2.2.7d | D.1/D.2 IMP Identification and Status Details | D.2.1 Has the IMP to be used in the trial a marketing authorisation | 'D.2.1.2.1 Is this the Member State concerned with this application' must be left not answered if 'D.2.1.2 country which granted the MA' is 'European Union', and is mandatory when D.2.1.2 is not 'European Union'. |
| FEAT6.2.2.9 | D.1/D.2 IMP Identification and Status Details | D.2.2 IMP to be used in the CT has a marketing authorisation | If answering D.2.2 all subsections should be answered i.e. (D.2.2.1, D.2.2.2, D.2.2.3, and D.2.2.4) 'Yes' or 'No' and at least one must be 'Yes'. |
| FEAT6.2.1.04 | D.1/D.2 IMP Identification and Status Details | D.2.1 Has the IMP to be used in the trial a marketing authorisation | It is mandatory to answer at least 'D.3.1 IMP Name', OR 'D.3.2 IMP Code', if question 'D.2.1 IMP has MA' is answered "No". |
| FEAT6.2.2.08 | D.1/D.2 IMP Identification and Status Details | D.2.1.1.4 Is the IMP modified in relation to its Marketing Authorisation | If question D.2.1.1.4 is answered "Yes" then question D.2.1.1.4.1 should be answered. |
| FEAT6.2.1.09 | D.3.8 to D.3.10 IMP Identification Details (Active Substances) | D.2.2.3 The products to be administered as IMPs are defined as belonging to an ATC group | It is mandatory to identify at least one active substance for every IMP except when D.2.2.3 Products to be administered as IMP belonging to ATC Group or D.2.2.4 Other are answered Yes. |
| FEAT6.2.2.15 | D.1/D.2 IMP Identification and Status Details | D.2.4 Has the use of the IMP been previously authorised in a clinical trial conducted by the sponsor in the Community | 'D.2.4 IMP previously used for CT in community' is a mandatory field and if "Yes" so is D.2.4.1 for at least one MS. |
| FEAT6.2.1.05 | D.1/D.2 IMP Identification and Status Details | D.2.5 Has the IMP been designated in this indication as an orphan drug in the Community | 'D.2.5.1 Orphan drug number' should only be answered if 'D.2.5 IMP is orphan drug' is a "Yes". |
| FEAT6.2.2.16 | D.1/D.2 IMP Identification and Status Details | D.2.6 Has the IMP been the subject of scientific advice related to this clinical trial | -'D.2.6' is a mandatory field and if it is ticked "Yes", question 'D.2.6.1' should be completed and at least one of the subquestions 'D.2.6.1.1 SA from CHMP' and 'D.2.6.1.2 SA from NCA' should be answered and one should be "Yes". |
| FEAT6.2.1.06 | D.3 Description of the IMP | D.3.4 Pharmaceutical Form | 'D.3.4 IMP Pharmaceutical Form' is a mandatory field, except where any part of D.2.2 is answered Yes and the trial may use different pharmaceutical forms of that active substance. |
| FEAT6.2.1.57 | D.3 Description of the IMP | D.3.6.1 For first trial only | If E.7.1.1 First Admin to Humans = 'Yes' then D.3.6.1 fields should always be completed and D.3.6.2 fields should be left blank. |
| FEAT6.2.1.61 | D.3 Description of the IMP | D.3.6.2 For all trials | If E.7.1.1 First Admin to Humans = 'No' then D.3.6.2 fields should always be completed and D.3.6.1 fields should be left blank. |
| FEAT6.2.1.60 | D.3 Description of the IMP | D.3.7 Route(s) of Administration of this IMP | D.3.7 must be answered except if D.2.2 is answered (i.e. at least one of D.2.2.1, D.2.2.2, D.2.2.3 or D.2.2.4 is Yes). |
| FEAT6.2.1.11a | D.3.8 to D.3.10 IMP Identification Details (Active Substances) | D.3.10 Strength | D.3.10, D.3.10.1,2,3 are Mandatory fields except where 'D.2.2.2 Has local site products' is yes |
| FEAT6.2.1.11b | D.3.8 to D.3.10 IMP Identification Details (Active Substances) | D.3.10 Strength | D.3.10.3 should be a single numeric value in the left field (can be a decimal) or in both fields only where D.3.10.2 is "RANGE" |
| FEAT6.2.1.12 | D.3.11 Type of IMP | D.3.11.1 Of chemical origin/D.3.11.2 Of biological/ biotechnological origin/D.3.11.3 Advanced Therapy IMP | 'At least one of D.3.11.1 Chemical origin AS', 'D.3.11.2 Biological origin AS' and 'D.3.11.3 Advanced Therapy IMP' should be "Yes". |
| FEAT6.2.1.13 | D.3.11 Type of IMP | D.3.11.1/2 Active Substance Origin | If 'D.3.11.1 Chemical origin AS' is answered "Yes" and 'D.3.11.2 Biological origin AS' is answered "No", then 'D.3.11.3.1-4 and D.3.11.6-10 should be answered "No". |
| FEAT6.2.1.46 | D.3.11 Type of IMP | D.3.11.3.5 Has the Committee on Advanced therapies issued a classification for this product | You should only provide the classification and its reference number if the Committee on Advanced therapies issued a classification for this product. |
| FEAT6.2.1.49a | D.3.11 Type of IMP | D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy | If D.3.11.3.4 OR D.3.11.4 = 'Yes' then Section D.7 should be completed. D.7.1, D.7.2 and D.7.3 should be answered. At least one of D.7.4.1, D.7.4.2, D.7.4.3, D.7.4.4, D.7.4.5 should be 'Yes'. If D.7.4.1.1 Medical device have a CE Mark = 'Yes' then D.7.4.1.1.1 Notified body should be completed. |
| FEAT6.2.1.49b | D.3.11 Type of IMP | D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy | If D.7.4.1.1 Medical device have a CE Mark = 'Yes' then D.7.4.1.1.1 Notified body should be completed. |
| FEAT6.2.2.17 | D.3.11 Type of IMP | D.3.11.11 Herbal medicinal product | - 'D.3.11.10.1 GMP MP Auth granted', 'D.3.11.10.2 GMP MP Auth pending' are only mandatory when the parent question is yes. |
| FEAT6.2.1.17 | D.3.11 Type of IMP | D.3.11.13.1 If 'another type of medicinal product' specify the type of medicinal product | D.3.11.13.1 Other MP Specification is only mandatory when the parent question is answered "Yes". |
| FEAT6.2.2.31 | D.3.11 Type of IMP | D.3.13.1 If yes, are there risk factors identified, according to the guidance FIH | You should only provide the risk factors identified, according to the guidance FIH if the IMP is to be used in a first-in-human clinical trial. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.1.2 and D.1.3 Category | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.7c | D.1/D.2 IMP Identification and Status Details | D.2.1 Has the IMP to be used in the trial a marketing authorisation | D.2.1 must be answered as Yes or No in accordance with the IMP in question, not answered is not an acceptable response. |
| FEAT6.2.2.14 | D.1/D.2 IMP Identification and Status Details | D.2.3 IMPD Submitted | 'D.2.3.1 Full IMPD submitted', 'D.2.3.2 Simplified IMPD submitted' and 'D.2.3.3 Only SmPC submitted' are mandatory, but only one may be "Yes" and the other two should be "No". |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.3.1 Full IMPD | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.3.2 Simplified IMPD | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.3.3 Summary of product characteristics (SmPC) only: | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.4 Has the use of the IMP been previously authorised in a clinical trial conducted by the sponsor in the Community? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.5 Has the IMP been designated in this indication as an orphan drug in the Community? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.1/D.2 IMP Identification and Status Details | D.2.6 Has the IMP been the subject of scientific advice related to this clinical trial? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3 Description of the IMP | D.3.4.1 Is this a specific paediatric formulation? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3 Description of the IMP | D.3.5 Maximum duration of treatment of a subject according to the protocol | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.1 Of chemical origin? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.2 Of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3 Advanced Therapy IMP (ATIMP) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3.1 Somatic cell therapy medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.16 | D.4 Somatic Cell Therapy Investigational Medicinal Product | D.3.11.3.1 Somatic cell therapy medicinal product | If 'D.3.11.3.1 Somatic cell therapy MP' is "Yes" then one but only one of the subquestions of section D.4.1 should also be "Yes" and one but only one of the subquestions of section D.4.2 should also be Yes (and vice versa). If 'D.3.11.3.1 Somatic cell therapy MP' is No then all the parts of section 'D.4 Somatic Cell Therapy IMP' is "No" (and vice versa). |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3.2 Gene therapy medical product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3.3 Tissue Engineered Product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.48 | D.3.11 Type of IMP | D.3.11.3.3 Tissue Engineered Product | If 'D.3.11.3.3 Tissue Engineered Product' is "Yes" then one but only one of the sub questions of section D.6.1 should also be "Yes", and one but only one of the sub questions of section D.6.2 should also be "Yes" (and vice versa). |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device)? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.3.5 Has the Committee on Advanced therapies issued a classification for this product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.5 radiopharmaceutical medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.6 immunological medicinal product (such as vaccine, allergen, immune serum)? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.7 plasma derived medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.8 Extractive medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.9 Recombinant medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.10 medicinal product containing genetically modified organisms? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.11 Herbal medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.12 Homeopathic medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.11.13 Another type of medicinal product? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.3.11 Type of IMP | D.3.13 Is it an IMP to be used in a first-in-human clinical trial? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.10 | D.3.8 to D.3.10 IMP Identification Details (Active Substances) | D.3.8 AS INN, D.3.9.1 CAS Number, D.3.9.2 Current sponsor code, D.3.9.3 Other descriptive name | D.3.8 must be completed and one of D.3.9.1, D.3.9.2, D.3.9.3 should be answered. |
| FEAT6.2.4 | D.8 Information on the Placebo | D.8.5.2 Is it otherwise identical to the IMP? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.28 | D.8 Information on the Placebo | D.8.5.2 Is it otherwise identical to the IMP? | If 'D.8.5.2 Is it otherwise identical to the IMP?' is No then 'D.8.5.2.1 If composition is not otherwise identical, specify the major ingredients' must be completed. |
| FEAT6.2.4 | D.8 Information on the Placebo | D.8.3 Pharmaceutical form | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | D.8 Information on the Placebo | D.8.4 Route of administration | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.64 | D.8 Information on the Placebo | D.8.5 Which IMP(s) is it a placebo for? | Placebo should be associated with at least one valid IMP. |
| FEAT6.2.1.59 | D.9 Site(s) where the qualified person certifies batch release | D.9 Site(s) where the qualified person certifies batch release | Each IMP must be identified under either 'D.9.1 IMPs and placebos for which no responsible site needs to be identified' or 'D.9.2 Add Responsible Site'. |
| FEAT6.2.1.59 | D.9 Site(s) where the qualified person certifies batch release | D.9 Site(s) where the qualified person certifies batch release | Each IMP must be identified under either 'D.9.1 IMPs and placebos for which no responsible site needs to be identified' or 'D.9.2 Add Responsible Site'. |
| FEAT6.2.2.19 | D.9 Site where the qualified person certifies batch release | D.9.2 Responsible Site | Where products are to be identified under 'D.9.2 Responsible site', 'D.9.2.1 and D.9.2.2 As a manufacturer, importer or both?', 'D.9.2.3 Site organisation name' and 'D.9.2.4.4 Country' are mandatory and must be completed. |
| FEAT6.2.2.20 | D.9 Site where the qualified person certifies batch release | D.9.2.5 Manufacturer authorisation number | 'D.9.2.5.1 If no authorisation, give the reasons' is mandatory if 'D.9.2.5 Manufacturer authorisation number' is blank and vice versa. One and only one must be completed. |
| FEAT6.2.1.30 | E.1.2 MedDRA information | E.1.2 MedDRA information | All MedDRA information to be provided. |
| FEAT6.2.1.31 | E.2 Objective of the Trial | E.2.3 Is there a sub-study | 'E.2.3 Has a sub-study' is a mandatory field and if it is "Yes" then 'E.2.3.1 Sub-study details' should also be completed. |
| FEAT6.2.1.32a | E.6 and E.7 Scope of the Trial, Trial Type and Phase | E.6 Scope of the trial | At least one of the answers from 'E.6.1 Diagnosis' to 'E.6.13 Others' should be 'Yes'. |
| FEAT6.2.1.32b | E.6 and E.7 Scope of the Trial, Trial Type and Phase | E.6 Scope of the trial | If 'E.6.13 Others' is 'Yes' then the applicant must specify the scope of the trial in 'E.6.13.1'. |
| FEAT6.2.1.33a | E.6 and E.7 Scope of the Trial, Trial Type and Phase | E.7 Trial type and phase | At least one of 'E.7.1 Human pharmacology (Phase I)' (including E.7.1.x subfields) to 'E.7.4 Therapeutic use (Phase IV)' should be answered 'Yes'. |
| FEAT6.2.1.33c | E.6 and E.7 Scope of the Trial, Trial Type and Phase | E.7 Trial type and phase | If 'E.7.1 Human pharmacology (Phase I)' is 'Yes' then at least one of the subfields in E.7.1 should be answered 'Yes'. |
| FEAT6.2.1.33b | E.6 and E.7 Scope of the Trial, Trial Type and Phase | E.7.1.3 Other | 'E.7.1.3.1 Trial type Other specification' should be answered if the parent question is answered "Yes". |
| FEAT6.2.1.34a | E.8 Design of the Trial | E.8.1 Controlled | If 'E.8.1 Controlled' is "Yes" then questions E.8.1.1 to E.8.1.7 and E.8.2 sub-questions are mandatory. |
| FEAT6.2.1.34b | E.8 Design of the Trial | E.8.1 Controlled | If 'E.8.1 Controlled is "No" or "Not Answered" then questions E.8.1.3 to E.8.1.6 and E.8.2 sub-questions should be "Not Answered" or "No". |
| FEAT6.2.1.55 | E.8 Design of the Trial | E.8.1 Controlled | If the answer to 'E.8.1 Controlled' is "Yes" then at least one of the sub questions of section 'E.8.2 Specify the comparator' should be answered "Yes" and 'E.8.2.4 Number of treatment arms in the trial' should be answered. |
| FEAT6.2.1.35 | E.8 Design of the Trial | E.8.1.2, E.8.1.3 and E.8.1.4 | Only one of the questions 'E.8.1.2 Trial design Open', 'E.8.1.3 Trial design Single blind' or 'E.8.1.4 Trial design Double blind' should be answered "Yes". |
| FEAT6.2.1.36 | E.8 Design of the Trial | E.8.1.7 Other | If 'E.8.1.7 Trial design Other' is answered "Yes" then the related free text field should be completed. |
| FEAT6.2.1.38 | E.8 Design of the Trial | E.8.2.3 Other Comparator | If 'E.8.2.3 Other ' is "Yes" and E.8.2.3.1 If 'other', specify the comparator' should be completed. |
| FEAT6.2.1.39 | E.8 Design of the Trial | E.8.4 Multiple sites in Member State | 'E.8.4 Multiple sites in the Member State concerned (see also Section G)' is a mandatory field and if answered "Yes" then question 'E.8.4.1 Number of sites anticipated in Member State concerned' should be answered. |
| FEAT6.2.2.21 | E.8 Design of the Trial | E.8.5 Multiple Member States | If E.8.5 is answered "Yes" then question E.8.5.1 should be answered. If answered "No" then E.8.5.1 should not be answered. |
| FEAT6.2.2.34 | E.8 Design of the Trial | E.8.6.4 Number of sites anticipated outside of the EEA | If 'E.8.6.1 Trial being conducted both within and outside the EEA' or 'E.8.6.2 Trial being conducted completely outside of the EEA' are "Yes" then provide the information on 'E.8.6.4 If E.8.6.1 or E.8.6.2 are yes, specify the number of sites anticipated outside of the EEA'. |
| FEAT6.2.2.22 | E.8 Design of the Trial | E.8.9 Initial estimate of the duration of the trial | 'E.8.9.1 Initial estimate of the duration of the trial in the Member State concerned' should be completed if E.8.5 = Yes and 'E.8.9.2 Initial estimate of the duration of the trial all countries concerned by the trial' should be completed if 'E.8.6.1 Trial being conducted both within and outside the EEA' = Yes. The total aggregate Years + Months + Days should be greater or more than zero. |
| FEAT6.2.1.29 | E.1.2 MedDRA information | E.1.1 Specify the medical condition(s) to be investigated/E.1.2 MedDRA | One of 'E.1.1 Medical condition' or 'E.1.2 MedDRA' are mandatory, both may also be completed. |
| FEAT6.2.4 | E.1 Medical condition or disease under investigation. | E.1.1.1 Medical condition in easily understood language | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.1 Medical condition or disease under investigation. | E.1.1.2 Identify the therapeutic area | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.1 Medical condition or disease under investigation. | E.1.3 Is any of the conditions being studied a rare disease? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.2 Objective of the Trial | E.2.1 Main objective of the trial | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.2 Objective of the Trial | E.2.2 Secondary objectives of the trial | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.2 Objective of the Trial | E.2.3 Is there a sub-study? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.3 Principal inclusion criteria (list the most important, max 5000 characters) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.4 Principal exclusion criteria (list the most important, max 5000 characters) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.5.1 Primary end point(s) (max 5000 characters) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.5.1.1 Timepoint(s) of evaluation of this end point | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.5.2 Secondary end point(s) (max 5000 characters) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.3 and E.4 and E.5 Principal inclusion criteria, Principal exclusion and Primary end point(s) | E.5.2.1 Timepoint(s) of evaluation of this end point | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.1 Diagnosis | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.2 Prophylaxis | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.3 Therapy | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.4 Safety | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.5 Efficacy | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.6 Pharmacokinetic | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.7 Pharmacodynamic | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.8 Bioequivalence | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.9 Dose response | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.10 Pharmacogenetic | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.11 Pharmacogenomic | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.12 Pharmacoeconomic | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.6 Scope of the trial | E.6.13 Others | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.1 Human pharmacology (Phase I) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.1.1 First administration to humans | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.1.2 Bioequivalence study | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.1.3 Other | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.2 Therapeutic exploratory (Phase II) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.3 Therapeutic confirmatory (Phase III) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.7 Trial type and phase | E.7.4 Therapeutic use (Phase IV) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.1 Controlled | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.3 Single site in the Member State concerned (see also Section G) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.58 | E.8 Design of the Trial | E.8.3 Single site in the Member State concerned | One of 'E.8.3 Single site in the Member State concerned (see also Section G)'or 'E.8.4 Multiple sites in the Member State concerned (see also Section G)'' must be answered 'Yes'. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.4 Multiple sites in the Member State concerned (see also Section G) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.5 Multiple Member States | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.6.1 Trial involving countries outside the EEA? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.7 Trial having an independent data monitoring committee? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | E.8 Design of the Trial | E.8.8 Definition of the end of the trial and justification in the case where it is not the last visit of the last subject undergoing the trial | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.40a | F. Population of Trial Subjects | F.1.1 Are the trial subjects under 18 | If 'F.1.1 Are the trial subjects under 18?' is 'Yes'' then 'Number of subjects for this age range' should be completed and greater than 0. |
| FEAT6.2.1.40b | F. Population of Trial Subjects | F.1.1 Are the trial subjects under 18 | If 'F.1.1 Are the trial subjects under 18?' is 'Yes' then one of fields F.1.1.2 to F.1.1.6 should be also 'Yes'. |
| FEAT6.2.1.40c | F. Population of Trial Subjects | F.1.1 Are the trial subjects under 18 | If F.1.1 is "Yes" you should provide number of subjects for this age range and all sub-questions should be answered and at least one of F.1.1.1 to F.1.1.6 should be "Yes". Also, for all elements that are 'Yes', the relevant values of F.1.1.1.1 to F.1.1.6.1 should be greated than 0. |
| FEAT6.2.1.41 | F. Population of Trial Subjects | F.1.2 Adults (18-64 years) | If 'F.1.2 Adults (18-64 years)' is 'Yes' then 'F.1.2.1 Number of subjects for this age range' should be completed and greater than 0. |
| FEAT6.2.1.42 | F. Population of Trial Subjects | F.1.3 Elderly (>=65 years) | If 'F.1.3 Elderly (>=65 years)' is 'Yes' then 'F.1.3.1 Number of subjects for this age range' should be completed and greater than 0. |
| FEAT6.2.1.47 | F. Population of Trial Subjects | F.3.3 Specific vulnerable populations | - If 'F.3.3 Specific vulnerable populations' is "Yes", F.3.3.1 to F.3.3.7 are mandatory and at least one should be answered "Yes". - If 'F.3.3 Specific vulnerable populations' is "No", F.3.3.1 to F.3.3.7 should be answered "No" or "Not Answered". |
| FEAT6.2.2.23 | F. Population of Trial Subjects | F.3.3.6 subjects incapable of giving consent personally | Question 'F.3.3.6.1 Population subjects incapable of giving consent details' should be answered if the answer to the parent question is "Yes". |
| FEAT6.2.2.24 | F. Population of Trial Subjects | F.3.3.7 Others | If 'F.3.3.7 Others' is "Yes" then 'F.3.3.7.1 If others, specify the specific vulnerable populations' must be answered. |
| FEAT6.2.1.63 | F.4 Planned number of subjects to be included | F.4.2.1 In the EEA/F.4.2.2 In the whole clinical trial | If one of E.8.5 or E.8.6.1 is 'Yes' then F.4.2.1 and F.4.2.2 must be completed. |
| FEAT6.2.4 | F.1 Age Range | F.1.1 Are the trial subjects under 18? | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.54 | F.1 Age Range | F.1.1 Are the trial subjects under 18?/F.1.2 Adults (18-64 years)/ F.1.3 Elderly (>=65 years) | At least one of F.1.1, F.1.2, F.1.3 must be answered 'Yes'. |
| FEAT6.2.4 | F.1 Age Range | F.1.2 Adults (18-64 years) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.1 Age Range | F.1.3 Elderly (>=65 years) | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.1.62 | F.2 Gender | F.2.1 Female/F.2.2 Male | At least one of F.2.1, F.2.2 must be answered 'Yes'. |
| FEAT6.2.4 | F.2 Gender | F.2.1 Female | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.2 Gender | F.2.2 Male | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.3 Group of trial subjects | F.3.1 Healthy volunteers | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.3 Group of trial subjects | F.3.2 Patients | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.3 Group of trial subjects | F.3.3 Specific vulnerable populations | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.4 Planned number of subjects to be included | F.4.1 In the member state | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | F.5 Plans for treatment or care after the subject has ended the participation in the trial | F.5 Plans for treatment or care after the subject has ended the participation in the trial | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.25 | G.1 and G.2 Investigator Details | G.1/G.2 Investigator Details | There should be at least one investigator (the principal of a single centre or coordinator of a multicentre trial). |
| FEAT6.2.2.25 | G.1 and G.2 Investigator Details | G.1 and G.2 Investigator Details | There should be at least one investigator (the principal of a single centre or coordinator of a multicentre trial). |
| FEAT6.2.4 | G.1 and G.2 Investigator Details | G.1.3/G.2.3 Family name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | G.1 and G.2 Investigator Details | G.1.5/G.2.5 Institution name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.4 | H. Ethics Committee | H.2.1 Ethics committee name | You must complete all mandatory fields with a value and where appropriate provide an answer Yes or No. A field not completed will generate errors listed in the validation report. |
| FEAT6.2.2.12 | D.1/D.2 IMP Identification and Status Details | D.2.2.1 In the protocol, is treatment defined only by active substance | - If 'D.2.2.1 Treatment defined only by Active Substance' is answered with "Yes" then 'D.2.2.2 Combinations of marketed products' may be "Yes" or "No" and 'D.2.2.3 IMP defined by ATC Group' and 'D.2.2.4 IMP identification other' should be "No". |
| FEAT6.2.2.13 | D.1/D.2 IMP Identification and Status Details | D.2.2.2 In the protocol, do treatment regimens allow different combinations of marketed products used according to local clinical practice at some or all investigator sites in the MS | - If 'D.2.2.2 Combinations of marketed products' is "Yes" then 'D.2.2.1 Treatment defined only by AS' may be "Yes" or "No" and 'D.2.2.3 IMP defined by ATC Group' and 'D.2.2.4 IMP identification other' should be "No". |
| FEAT6.2.2.10 | D.1/D.2 IMP Identification and Status Details | D.2.2.3 The products to be administered as IMPs are defined as belonging to an ATC group | - If 'D.2.2.3 IMP defined by ATC Group' is "Yes" then 'D.2.2.1 Treatment defined only by AS' 'D.2.2.2 Combinations of marketed products' and 'D.2.2.4 IMP identification other' should be "No". |
| FEAT6.2.1.07 | D.1/D.2 IMP Identification and Status Details | D.2.2.3 The products to be administered as IMPs are defined as belonging to an ATC group | - Where 'D.2.2.3 IMP defined by ATC Group' is answered "Yes" at least one ATC code is mandatory in 'D.3.3 IMP ATC Code' |
| FEAT6.2.2.11a | D.1/D.2 IMP Identification and Status Details | D.2.2.4 Other | If D.2.2.4 is "Yes" then D.2.2.1, D.2.2.2 and D.2.2.3 should be "No" and the applicant should give details in this section on the specific situation set up for the trial. |
| FEAT6.2.2.11b | D.1/D.2 IMP Identification and Status Details | D.2.2.4 Other | The fields 'D.2.2.4.1 IMP identification other specification' should not be answered when the parent question 'D.2.2.4 IMP identification other' is answered 'No'. |
| FEAT6.2.1.20 | D.4 Somatic Cell Therapy Investigational Medicinal Product | D.4.1.3 Xenogeneic | The subquestion to question D.4.1.3 should be completed if D.4.1.3 is "Yes". It should be blank if D.4.1.3 is "No" or "Not Answered". |
| FEAT6.2.1.21 | D.4 Somatic Cell Therapy Investigational Medicinal Product | D.4.2.2 Differentiated cells | The subquestion 'D.4.2.2.1 If differentiated, specify the type of cells' to question D.4.2.2 should be completed if D.4.2.2 is "Yes". It should be blank if D.4.2.2 is "No" or "Not Answered". |
| FEAT6.2.1.22 | D.4 Somatic Cell Therapy Investigational Medicinal Product | D.4.2.3 Others | The subquestion to question 'D.4.2.3 Somatic Cell Therapy type other' should be completed if D.4.2.3 is answered "Yes". It should be blank if D.4.2.3 is "No" or "Not Answered". |
| FEAT6.2.1.23a | D.5 Gene Therapy Imps | D.5.4.1 Nucleic acid (e.g. plasmid) | The subquestions to question 'D.5.4.1 Gene therapy nucleic acid' should be completed if D.5.4.1 is answered "Yes". They should be blank or "No" if D.5.4.1 is "No". |
| FEAT6.2.1.23b | D.5 Gene Therapy Imps | D.5.4.1 Nucleic acid (e.g. plasmid) | The subquestions to question 'D.5.4.1 Gene therapy nucleic acid' should be blank if D.5.4.1 is answered "Yes". They should be blank or "No" if D.5.4.1 is "No". |
| FEAT6.2.1.26 | D.5 Gene Therapy Imps | D.5.5 Does the IMP contain genetically modified cells | The subquestions to 'D.5.5 GM Cells' should be completed if D.5.5 is "Yes". They should be blank or "No" if D.5.5 is answered "No". |
| FEAT6.2.1.24 | D.5 Gene Therapy Imps | D.5.4.2 Viral vector | The subquestion to question D.5.4.2 should be completed if D.5.4.2 is "Yes". It should be blank if D.5.4.2 is "No" or "Not Answered". |
| FEAT6.2.1.25 | D.5 Gene Therapy Imps | D.5.4.3 Others | The subquestion to question D.5.4.3 should be completed if D.5.4.3 is "Yes". It should be blank if D.5.4.3 is "No" or "Not Answered". |
| FEAT6.2.1.27 | D.5 Gene Therapy Imps | D.5.5.3 Xenogeneic | The subquestion to question D.5.5.3 should be completed if D.5.5.3 is "Yes". It should be blank if D.5.5.3 is "No" or "Not Answered". |
| FEAT6.2.1.18 | D.3.11 Type of IMP | D.3.11.3.2 gene therapy medicinal product | If 'D.3.11.3.2 Gene Therapy MP' is "Yes" then section 'D.5 Gene Therapy MP' is mandatory (and vice versa). If 'D.3.11.3.2 Gene Therapy MP' is No then all of D.5 should be No. |
| FEAT6.2.1.50 | D.6 Tissue Engineered Product | D.6.1.3.1 If yes, specify the species of origin | The field 'D.6.1.3.1 Tissue Engineered xenogeneic species' should only be completed if the parent question is answered yes. |
| FEAT6.2.1.51 | D.6 Tissue Engineered Product | D.6.2.3.1 If 'others', specify the type of cells | The field 'D.6.2.3.1 Tissue Engineered Other Specification' should only be completed if the parent question is answered yes. |
| FEAT6.2.1.56 | D.6 Tissue Engineered Product | D.6.2.2 Differentiated cells | If the information is provided in D.6.2.2 then details should be provided in D.6.2.2.1. |
| FEAT6.2.1.52 | D.7 Products containing devices | D.7.4.1.1 Does this medical device have a CE mark | The field 'D.7.4.1.1 Device has CE mark' should only be completed if the parent question is answered "Yes". |
| FEAT6.2.1.53 | D.7 Products containing devices | D.7.4.5.1 If 'other', specify | The field 'D.7.4.5 Device Other' should only be completed if the parent question is answered "Yes". |