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. You must complete all mandatory fields 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. 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. - 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". 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'. You must complete all mandatory fields 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 and D.2.1.2 must be answered. 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". 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.2.5.1 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.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. 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. You must complete all mandatory fields 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 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. You must complete all mandatory fields 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. D.3.11.13.1 Other MP Specification is only mandatory when the parent question is answered "Yes". 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. One of 'E.1.1 Medical condition' or 'E.1.2 MedDRA' are mandatory, both may also be completed. 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. You must complete all mandatory fields 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. You must complete all mandatory fields 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.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. 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". You must complete all mandatory fields 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 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. 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'. You must complete all mandatory fields 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. '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. You must complete all mandatory fields 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. You must complete all mandatory fields 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.