Pan African Clinical Trial Registry (PACTR)
- Funding Agency: The European & Developing Countries Clinical Trials Partnership (EDCTP)
- Managing Agency: South African Cochrane Centre (SACC)
The PACTR is currently funded by the EDCTP and managed by the South African Cochrane Centre (SACC), an intra-mural research unit of the South African Medical Research Council (MRC). The SACC is funded by the MRC and the PACTR is funded for the following year on a no-cost extension by the EDCTP to complete its development phase.
- Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- Does the Registry have documented Standard Operating Procedures (SOPs)?
- Are mechanisms in place to ensure compliance with these SOPs? (eg staff training)
- Description of the compliance mechanisms:
A workshop will be held for all members of the Working Group (based at the SACC) to ensure compliance with the SOPs. The SOPs outline a number of checks and balances to ensure staff compliance with our protocols including advisement on SOP protocol in monthly working group meetings and utilizing a clearly outlined chain of command in decision-making. Induction for the SOPs will be mandatory for any new staff member joining the PACTR team.
- Does the Registry agree to participate in the development of Guidelines for Clinical Trial Registries?
- Can the Registry collect and publicly display the WHO Trial Registration Data Set (TRDS)?
Yes, Click here to view the details.
- Languages in which the registered information is displayed:
- What quality control measures does your Registry have in place to make sure that all 20 items in the WHO TRDS are as complete and accurate as possible?
An administrator contacts the registrant to verify details. Detailed SOPs have been developed for the use and administration of the PACTR which will be followed throughout all the processes of trial registration.
- Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration?
Not applicable: When a registrant registers a trial, the administrator will check the data to ensure that it complies with the WHO Trial Registration Data Set. Should any of the information be missing, the administrator will contact the registrant to complete the information. Only once all the information has been completed, will a trial number be assigned.
- Does the Registry agree to submit the WHO Trial Registration Data Set, in English, to the Central Repository?
- Does the Registry agree to keep registered information up-to-date?
- Does the Registry agree to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked?
- Does the Registry agree to never to remove a trial once it has been registered?
- Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- The web address where this information is displayed:
http://www.pactr.org and click on the link to “governance” on the left hand side of the home page
- Does the Registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a Collaborating Registry in the Registry Network?
- Is the Registry searchable over the Internet at no charge?
- Is the Registry open to all prospective registrants?
- From which countries will the Registry accept trials for registration?
All Countries in Africa