H. Competent Authority/Ethics Committee Information

Task topic including steps necessary for completing Section H. Competent Authority/Ethics Committee Information in a Clinical Trial Application draft.

Complete the current status of the application to the Ethics Committee / National Competent Authority.

The details surrounding the completion of the subsections can be viewed below, or by moving the mouse over the field level help adjacent to fields.

H. National Competent Authority

Complete the current status of the application to the National Competent Authority.

  1. In field H.2.1, click in the free text field and enter the full name of the NCA concerned with the Clinical Trial Application.
  2. In free text fields H.2.2, please provide the full postal address of the above identified NCA.
  3. In field H.2.2.4, click the drop-down list to select the Country in which the NCA is based.
  4. In field H.2.2.4,enter the date on which the application was submitted to the National Competent Authority concerned in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the start date.
  5. In field H.3.1/H.3.2/H.3.3, select the status of the NCA Authorisation from drop-down list.
  6. If the status selected was 'Given' in the above field, please enter the date on which the application was authorised by the National Competent Authority in field H.3.3.1 in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the start date.
  7. In field H.3.3.2/H.3.3.3, click the drop-down arrow to select whether the authorisation was accepted, or not accepted by the applicant.
  8. If 'Not accepted' was chosen above, click in the free text field H.3.3.3.1 and include reasons for non-acceptance by the applicant of National Competent Authority Authorisation (up to 1000 characters).
  9. If 'Not accepted' was chosen above, click in the free text field H.3.3.3.2 and enter the date on which the application is expected to be resubmitted to National Competent Authority in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the expected date of the resubmission
If the above steps are completed, including mandatory fields. the subsection is complete.

When all the fields are completed (in any order), click and you return to the H. Competent Authority/Ethics Committee Information screen.

H. Ethics Committee

Complete the current status of the application to the Independent Ethics Committee.

  1. In field H.2.1, click in the free text field and enter the full name of the Ethics Committee concerned with the Clinical Trial Application.
  2. In free text fields H.2.2, please provide the full postal address of the above identified Ethics Committee.
  3. In field H.2.2.4, click the drop-down list to select the Country in which the Ethics Committeeis based.
  4. In field H.2.2.4,enter the date on which the application was submitted to the Ethics Committee concerned in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the start date.
  5. In field H.3.1/H.3.2/H.3.3, select the status of the Ethics Committee's opinion from drop-down list.
  6. If the status selected was 'Given' in the above field (H.3.1/H.3.2/H.3.3), in field H.3.3.1 please enter the date on which the Ethics Committee concerned gave their opinion in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the start date.
  7. In field H.3.3.2/H.3.3.3, click the drop-down arrow to select whether the opinion given by the Ethics Committee was favourable, or not.
  8. If 'not favourable' was chosen above, click in the free text field H.3.3.3.1 and include reasons for the non-favourable Ethics Committee Opinion (up to 1000 characters).
  9. If 'not favourable' was chosen above, click in the free text field H.3.3.3.2 and enter the date on which the application is expected to be resubmitted to the Ethics Committee in the following format: YYYY-MM-DD. Alternatively, click the calendar and select the expected date of the resubmission.
If the above steps are completed, including mandatory fields. the subsection is complete.

When all the fields are completed (in any order), click and you return to the H. Competent Authority/Ethics Committee Information screen..

Once the entire section is completed to your requirements, including all sub-sections, it is suggested you return to the Clinical Trial Application Menu Overview.

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