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NEW SUBMISSION REQUIREMENTS


RE: NEW SUBMISSION REQUIREMENTS – Circular 3, Version 21/12/2022

Pharma-Ethics is trying to move away from hard copy correspondence. This information will be added to updated SOPs, but in the interim, please use this guideline when preparing documents for submission:

All correspondence and submissions WITH THE EXCEPTION OF NEW APPLICATIONS, MAJOR AMENDMENTS, RE-APPROVALS AND MINOR AMENDMENTS must be submitted electronically. We will no longer accept hard copies of these documents.

NB: We are experiencing problems when accessing the e-submission platform from the website. Please access the platform by using the following direct link:
https://healthresearchweb.org/en/api/login?keyP=pharmaethics


NEW APPLICATIONS
This notification applies to all NEW APPLICATIONS listed in Section 1 of SOP Booklet III.
The requirements for documents that need to be attached to the e-submission remains the same. However, we only require the following as part of the HARD COPY submissions:

  1. Submission Certificate
  2. Printed electronic application form
  3. A cover letter listing all the documents included with the e-submission
  4. Protocol Summary/Synopsis
  5. Proposed English written Participants Information and Informed Consent Documents
  6. Material Transfer Agreements that need to be signed by an Ethics Representative.
  7. Insurance Certificate
  8. SAHPRA Application or Approval
  9. Proof of registrations on the SANCTR registry

Please note: All the documents (protocol, informed consent, etc.,) included in new applications, must comply with the content and format requirements in the Pharma-Ethics SOPs and Templates. Failure to follow these guidelines, will result in a delay in feedback after the meeting.

 

MAJOR PROTOCOL AMENDMENTS
The requirements for documents that need to be attached to the e-submission remains the same. However, we only require the following as part of the HARD COPY submissions:

  1. Submission Certificate
  2. Printed Electronic Application Form
  3. A cover letter listing all the documents included with the e-submission
  4. Summary of the approved protocol
  5. Rationale for the amendment
  6. Summary of changes
  7. English Version of the revised PIC (where applicable), incorporating highlighted/tracked changes. No clean version of the amended PIC is required with hard copy.

ANNUAL RE-APPROVALS

The requirements for documents that need to be attached to the e-submission remains the same. However, we only require the following as part of the HARD COPY submissions:

  1. Submission Certificate
  2. Printed Electronic Application Form
  3. A cover letter listing all the documents included with the e-submission
  4. Protocol Summary
  5. Please note the following:
    1. Site details must be completed on the e-submission platform. It is not sufficient to only provide the signed status reports
    2. Protocol Violations per site only need to be reported with the application for re-approval. We do not require reporting of protocol deviations on a case-by-case basis.
    3. Major protocol/ethics/regulatory/GCP violations must be reported on a case-by-case basis
    4. Line Listings for the reporting period MUST be attached as a PDF to the e-submission, irrespective of whether it was sent on a previous occasion. No hard copies or CDs of line listings are required.

MINOR AMENDMENTS

  1. Minor amendments are only submitted as HARD COPIES.
  2. The requirements for documents that need to be attached is listed in Section 5 of SOP Booklet III

OTHER
The following documents must only be submitted as HARD AND ELECTRONIC COPIES:

  1. Response to queries

The following documents must only be submitted ELECTRONICALLY to melanie@pharma-ethics.co.za:

  1. Additional sites and investigators or changes to sites and investigators
  2. Additional questionnaires
  3. Changes to participant reimbursement
  4. Translation Certificates of study documents. Please DO NOT SUBMIT TRANSLATED DOCUMENTS.
  5. Updated Investigator’s Brochures
  6. Notifications of changes in site staff other than investigators

The following documents must only be submitted ELECTRONICALLY to cathy@pharma-ethics.co.za:

  1. Adverse drug reactions (as specified in Section 2.2 of SOP Booklet V)
  2. SUSARs (as specified in Section 2.3 of SOP Booklet V)
  3. Line Listings
  4. Annual Safety Updated Reports
  5. Other relevant safety information or reports
  6. Material Transfer Agreements
  7. Protocol Violations

PLEASE NOTE:

  1. If ADRs and SUSARs are not accompanied with the Pharma-Ethics cover sheet, it will not be acknowledged or reviewed.
  2. We cannot accept any of the above safety information in an encrypted or password protected format as this information is forwarded to reviewers who will not be able to access it.

NB: Hard copy submissions for new applications, major amendments and annual re-approvals that are not submitted in the format required in our SOPs (ring bound or lever arch file) will be returned to the applicant without being reviewed.

Please note, failure to comply with these requirements may result in documents getting lost or not being reviewed. As from 15 January 2022, incorrect submissions will not be accepted or reviewed.

If hard copy submissions of new applications, major amendments and annual re-approvals are not submitted as specified above, an additional fee will be charged for document destruction/shredding.

 

Please share this circular with your colleagues who may not be registered on the Pharma-Ethics website.