Study Progress Report

Nelson Mandela University researchers (staff and/or students) of currently active studies are required to complete and submit a progress report on an annual basis. This is a requirement of the National Health Research Ethics Council (NHREC). An active protocol is one for which an ethics closure report (RECH-008) has not been submitted and approved.

The date for the submission of annual progress reports is the 15 November 2023.

Failure to do so may result in the immediate suspension or termination of all data collection activities linked to the study.
 

Annual Ethics Progress Reports should not be confused with the Annual Faculty Progress Reports submitted by Postgraduate students.

 

Study progress report (for studies approved on MEOS - the Mandela Ethics Online System))

Progress reports for studies granted original ethics approval via MEOS must be submitted on MEOS one-calendar year after original approval was granted. 

  1. Refer to the MEOS How-to Manuals/Videos on the REC-H website.
  2. Log into MEOS using your Nelson Mandela University username and password.
  3. Click on the project for which an extension is required.
  4. Click the [Create Sub Form] button in the left-hand panel.
  5. Select REC-H: Progress-Extension/Closure Report and click [Create]. 
  6. Students are advised to share the form with their supervisors.
  7. Complete the form.
  8. Sign the form.
  9. Request the signature of the PRP (Primary Responsible Person).
  10. Once signed by all relevant parties, the form will be automatically submitted for review.

 

Study Progress Report (for studies approved using the current offline process)

Researchers are advised to familiarise themselves with these guidelines and instructions prior to completing and submitting a progress report for review. 

  1. Researchers are advised to consult the following material relevant to the study being reported on while completing the progress report:
    1. Copy(ies) of any requests and approvals for study amendments/extensions/renewals (if applicable)
    2. Copy(ies) of any reports for adverse events (if applicable)
    3. Copy(ies) of previous progress reports (if applicable)
    4. Access to participant consent/assent forms as well as any data that has already been collected
    5. Copy of the original approved application
       
  2. Download a copy of RECH-004 (Progress Report) template.
     
  3. Researchers should familiarise themselves with the instructions and terminology provided on pages 1 – 2.
     
  4. Complete the progress report in full – refer to the provided definition of terms on page 2 for assistance. Please note: It is a mandatory requirement that both PI and PRP initial each page and sign the Declaration section.
     
  5. Complete all required supporting documentation (if applicable) and label each Appendix correctly.
    1. Appendix 1: RECH-008 (Study Closure/Discontinuation Report)
    2. Appendix 2: Unreported violations/deviations since last progress report/study approval
    3. Appendix 3: RECH-006 (Amendment Request)
    4. Appendix 4: RECH-005 (Extension Request)
    5. Appendix 5: RECH-007 (Unreported Adverse Events  since last progress report/study approval)
       
  6. Submit the original signed approval letter and any signed extension letter(s), if applicable, as Appendix 8.
     
  7. Prepare the progress report for submission as per the instructions in the information block on page 1.
     
  8. Remove the information block (pages 1 – 2) from the progress report.
     
  9. Complete the inventory of Supporting Documentation on page 3.
     

Submit the progress report and supporting documentation for review to the relevant faculty administrator as well as REC-H (Terry.Adams@mandela.ac.za). Please note that the original signed approval letter and original approved application must be submitted with the report. 

 

Deadlines for Submission of Annual Progress Report (2023):

The date for submission of progress reports  and all supporting documentation in 2023 is the 15th November 2023.

Kindly note, extension of data collection activities is not an automatic process. Should any researcher require an extension of their approval period, they should follow the process for the Extension of a Study.


Which RECH forms should be submitted as part of the 2023 call for Annual Progress Reports?

NOTE: Only ONE scenario should be applicable linked to the period of approval of your study. This can be found on your letter of ethics approval and/or any extension letter(s) issued.

  1. For protocols approved or granted an extension between 1 October 2022 and 31 October 2022:
    1. For data collection that is still in progress/not yet commenced: If an extension form (RECH-005) has not been submitted to Faculty/RECH for review at the relevant October 2023 meeting, ethics approval will have lapsed and a NEW application must be submitted to the faculty committee for approval.
    2. For data collection that has been completed but there may be possible follow-up with participants: If an extension form (RECH-005) has not been submitted to Faculty/RECH for review at the relevant October 2023 meeting, ethics approval will have lapsed and a NEW application must be submitted to the faculty committee for approval.
    3. For data collection that has been completed and there will be no further follow-up with participants OR the study has closed/discontinued: RECH-004 form (progress report template) and RECH-008 form (study closure template) to be completed.
       
  2. For protocols approved or granted an extension between 1 November 2022 and 31 January 2023:
    1. For data collection that is still in progress/not yet commenced: RECH-004 form (progress report template) and RECH-005 form (extension template) to be completed.
    2. For data collection that has been completed but there may be possible follow-up with participants: RECH-004 form (progress report template) and RECH-005 (extension template) to be completed.
    3. For data collection that has been completed and there will be no further follow-up with participants OR the study has closed/discontinued: RECH-004 (progress report template) and RECH-008 (study closure template) to be completed.
       
  3. For protocols approved or granted an extension between 1 February 2023 and 30 September 2023:
    1. For data collection that is still in progress/not yet commenced: RECH-004 form (progress report template) to be completed.
    2. For data collection that has been completed but there may be possible follow-up with participants: RECH-004 form (progress report template) to be completed.
    3. For data collection that has been completed and there will be no further follow-up with participants OR study closed/discontinued: RECH-004 form (progress report template) and RECH-008 form (study closure template) to be completed.
       
  4. For protocols approved or granted an extension in October/November 2023:
    1. No progress report submission is required in 2023, reporting only due in 2024