SAHPRA CTF 1, 2 & 3   Submission to approval  tracking for all Applicants

We would like to thank all the members that were able to attend the webinar on the 01st September 2020.  As a follow up to the webinar, we would like to quantify the submission to approval timelines for the CTF1, 2 & 3.  

We have previously requested data on a tracker; however, we need to use the Survey monkey tool to receive consolidated data from all applicants. We encourage all applicants to participate to ensure the gathering of information. 

Instructions:

CT1: Please complete the tracker for each study submitted from 01 November 2019 submission date to date.

CTF2 and CTF 3: complete data from January 2020 to date. 

IPASA members - are not required to provide this information should they have already provided the data through the IPASA process. 

You are required to populate a form for each submission. We do apologies for the duplication however at this moment we do not have a database that can capture this information. 

Consent & confidentiality:

Completion of this tracker serve as consent for the storage and use of data by SACRA to represent the industry.  Only SACRA will have access to the organisation details and the organisational details will not be shared with SAHPRA or with third party.

SACRA will publish monthly stats on this information, and it will be shared with all applicants to represent South African status, you are requested to be as accurate when providing the information.

Due date: first due date 30 September 2020, every 30th day of the month thereafter

Thank you

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* 1. Company name 

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* 2. Name of Company representative completing the form

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* 3. Select application CTF1; CTF 2 or CTF 3

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* 4. Document if is a COVID-19 study, device or non-COVID-19 study

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* 5. Completion of the tracker date

Date
Time

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* 6. Submission date 

Date
Time

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* 7. Study SAHPRA tracking number/ reference number

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* 8. Date Screening checklist received

Date

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* 11. Date of Approval

Date
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