Rule ID CT Section    Field Description Rule Description

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.

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.
FEAT6.2.4 A. Trial Identification A.8 EMA Decision number of 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.
FEAT6.2.4 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.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.
FEAT6.2.1.44 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.1.3.4 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 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.
FEAT6.2.2.05a C. PIP Addressee Identification - C.1 Request to receive a copy of the CT Information data as XML 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. PIP Addressee Identification - C.1 Request to receive a copy of the CT Information data as XML 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.
FEAT6.2.2.12 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".
FEAT6.2.2.11a 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'.
FEAT6.2.2.7b 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 and D.2.1.2 must be answered.
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".
FEAT6.2.1.09 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.
FEAT6.2.1.05 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".
FEAT6.2.1.06 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.
FEAT6.2.1.60 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.
FEAT6.2.1.17 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".
FEAT6.2.4 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.
FEAT6.2.4 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.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.
FEAT6.2.4 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.
FEAT6.2.4 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.
FEAT6.2.1.10 D.3.8 to D.3.10 IMP Identification Details (Active Substances) D.3.8 INN - Proposed 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.8.3 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.
FEAT6.2.1.30 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.
FEAT6.2.2.22 E.8 Design of the Trial E.8.9 Initial estimate of the duration of the trial 'E.8.9.2 Initial estimate of the duration of the trial (years, months, days) in all countries concerned by the trial' should be completed. 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.
FEAT6.2.1.58 E.8 Design of the Trial E.8.3/E.8.4 One of 'E.8.3 Will this trial be conducted at a single site globally?' or 'E.8.4 Will this trial be conducted at multiple sites globally?' must be answered 'Yes'.
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.
FEAT6.2.4 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.8.6.2 Trial being conducted completely outside of 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.8.6.3 Specify the countries outside of the EEA in which trial sites are planned 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.8.6.4 Specify the number of sites anticipated outside of 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.
FEAT6.2.4 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.4.2.2 In the whole 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 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.
FEAT6.2.4 H. Ethics Committee H.4.1 Clinical trial has been reviewed and given the necessary approval(s) by the Regulatory Authority (where required) and by the Ethics Committee(s) 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.