Amendment to a Study

All amendments for studies originally approved on MEOS, must be submitted on MEOS.

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 amendment is required.
4. Click the [Create Sub Form] button in the left-hand panel.
5. Select REC-H: Amendment and click [Create]. 
6. Students are advised to share the form with their supervisors.
7. Complete the amendment form.
8. Sign the amendment 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.

 

The offline amendment process distinguishes between a minor amendment and a major amendment.

If the amendment involves only a change to the primary responsible person (PRP), primary investigator (PI) or any other researchers collaborating with the study, the procedure - Change in Study Researchers - must be followed.

Minor Amendments:

The procedure for requesting approval for a minor modification is by means of written communication on a signed letterhead to Imtiaz.Khan@mandela.ac.za citing the study reference number and providing a detailed description of each change, supported by a rationale for each change as well as any and all relevant revised documentation for each change.  One copy of each amended study document which clearly highlights the changes must be submitted (highlighting of changes can be implemented by means of tracked changes, striking through “old text” and showing the “new text” in bold, underlined or in italics, or similar).  Additionally, one clean copy of the each amended document should accompany the written request.  Failure to submit both copies of modified documents and/or rationale for proposed modifications will delay the review and approval process.

Additionally, a copy of the original signed application form and signed acknowledgement of approval letter must also form part of the documentation for a minor amendment.

Major Amendments:

Major amendments to a currently active study are subject to full REC-H review.  

A progress report (RECH-004) is required to accompany the request for any major amendment to a study. 

The procedure for requesting a major amendment to a study is:  

1. Download a copy of both the RECH-006 (Amendment Application) and RECH-004 (Progress Report) templates. These forms are intended to be comprehensive in order to assist you with inclusive responses with a view to prevent any delay in the review and approval of the request.
    
2. Researchers are required to familiarise themselves with the instructions and terminology provided on the first page of each form.
    
3. Complete the forms in full.  Provide suitable responses to each item on the forms.  Incomplete or incorrectly completed forms might result in a delay of the review and approval process, and ultimately on the ability of the study to continue.

The completed amendment application form (RECH-006), progress report (RECH-004), original signed approval letter and/or extension letter(s) (if applicable) and original approved application must be submited to Imtiaz.Khan@mandela.ac.za

Please note: If a title change is recommended by the examiner at the point of the external evaluation process i.e. for degree purposes, and it is ONLY a title change and there has not been a substantive change in research aims, methodology and data collections instruments as originally approved by faculty (low-risk) or REC-H (medium/high-risk), then the minutes of the FPGSC meeting at which the title change is approved may be forwarded to REC-H for noting. In such cases, the procedure outlined above for requesting approval for a minor amendment must not be followed. REC-H will note the change in title once the minutes of the FPGSC meeting is received.