There should always be at least one IMP. There should always be at least one 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Complete if known. 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. The 'B.2 Legal Representative' section should only be completed when 'B.1.3.4 Country' is not a member state. You should provide either a telephone number or fax number or email address for the sponsor organisation information on 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. 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. 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. 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. 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. Complete if known. 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. You should provide either a telephone number or fax number or email address for the legal representative 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. 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. 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. 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. 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. 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. 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. Complete if known. 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. You should provide either a telephone number or email address for the contact point designated by the sponsor for further information on 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. 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. 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. 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. 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. 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. 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. 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 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. 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. 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'. 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. D.2.1 must be answered as Yes or No in accordance with the IMP in question, not answered is not an acceptable response. 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. 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. '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'. 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'. 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". If question D.2.1.1.4 is answered "Yes" then question D.2.1.1.4.1 should be answered. 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. '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". 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. 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. 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. 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. '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. 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. 'D.2.5.1 Orphan drug number' should only be answered if 'D.2.5 IMP is orphan drug' is a "Yes". 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. -'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". '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. 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. 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. 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. 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. 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). D.3.10, D.3.10.1,2,3 are Mandatory fields except where 'D.2.2.2 Has local site products' is yes 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" 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. '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". 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". 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. 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. 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. 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). 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. 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. 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). 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. 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. You should only provide the classification and its reference number if 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. - '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. 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. 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. D.3.11.13.1 Other MP Specification is only mandatory when the parent question is answered "Yes". 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. 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. D.3.8 must be completed and one of D.3.9.1, D.3.9.2, D.3.9.3 should be answered. 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. 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. Placebo should be associated with at least one valid 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. 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. 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'. 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'. 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. '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. One of 'E.1.1 Medical condition' or 'E.1.2 MedDRA' are mandatory, both may also be completed. 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. 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. All MedDRA information to be provided. 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. 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. 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. 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. '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. 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. 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. 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. 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. 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. 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. At least one of the answers from 'E.6.1 Diagnosis' to 'E.6.13 Others' should be 'Yes'. If 'E.6.13 Others' is 'Yes' then the applicant must specify the scope of the trial in 'E.6.13.1'. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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'. 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'. 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. 'E.7.1.3.1 Trial type Other specification' should be answered if the parent question is answered "Yes". 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. 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. 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. 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. 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. 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. 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. 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. 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". 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. 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". If 'E.8.1.7 Trial design Other' is answered "Yes" then the related free text field should be completed. If 'E.8.2.3 Other ' is "Yes" and E.8.2.3.1 If 'other', specify the comparator' should be completed. 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. 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'. 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. '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. 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. 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. 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. 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'. 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. 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. '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. 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. At least one of F.1.1, F.1.2, F.1.3 must be answered 'Yes'. 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. 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'. 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. 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. 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. 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. 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. At least one of F.2.1, F.2.2 must be answered 'Yes'. 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. 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. 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. 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. 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. - 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". 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". If 'F.3.3.7 Others' is "Yes" then 'F.3.3.7.1 If others, specify the specific vulnerable populations' must be answered. 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. 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. 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. There should be at least one investigator (the principal of a single centre or coordinator of a multicentre trial). There should be at least one investigator (the principal of a single centre or coordinator of a multicentre 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. 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. 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. - 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". - 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". - 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". - 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' 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. 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'. 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". 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". 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". 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". 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". 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". 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". 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". 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". 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. The field 'D.6.1.3.1 Tissue Engineered xenogeneic species' should only be completed if the parent question is answered yes. The field 'D.6.2.3.1 Tissue Engineered Other Specification' should only be completed if the parent question is answered yes. If the information is provided in D.6.2.2 then details should be provided in D.6.2.2.1. The field 'D.7.4.1.1 Device has CE mark' should only be completed if the parent question is answered "Yes". The field 'D.7.4.5 Device Other' should only be completed if the parent question is answered "Yes".