Pan African Clinical Trials Registry (PACTR)
South African Cochrane Centre (SACC)
P.O. Box 19070
- Registry URL: http://www.pactr.org
- Registration URL: http://www.pactr.org
- Email: email@example.com
- 1. Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- 2. Is the Registry open to all prospective registrants (ICMJE), either internationally, or within one or more specific countries?
- 2.1. From which countries will the Registry accept trials for registration?
All countries in Africa
- 2.2. If the Registry is not open to ALL registrants (that is, accepts trials only from a particular sponsor, health care condition (eg cancer), intervention, etc) please specify which trials the Registry is open to.
- 3. Is the Registry able to collect and publicly display the WHO Trial Registration Data Set? (ICMJE)
- 4. Does the Registry endeavour to keep registered information up-to-date?
- 4.1. Does the Registry have a reminder system to facilitate the submission of updated information by the responsible registrant?
- 4.2. Does the Registry highlight or flag records that are not current (have not been updated in more than 12 months) so readers are aware that information contained in such records may not be current?
- 5. Does the Registry never remove a trial once it has been registered?
Quality and Validity
- 6. Does the Registry have a mechanism in place to ensure the validity of the registered data? (ICMJE)
- 6.1. Does the registry contact Responsible Registrants when one or more items in the Trial Registration Data Set are incomplete or potentially inaccurate?
- 6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
- 6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
- 6.4. Please briefly describe these compliance mechanisms.
- 7. Does the registry maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked?
- 8. It is desirable that Primary Registries participate in the development of the International Standards for Clinical Trial Registries. Does the Registry agree to participate in the development of these standards?
- 9. Is the WHO Trial Registration Data Set accessible to the public at no charge? (ICMJE)
- 10. Is the WHO Trial Registration Data Set electronically searchable? (ICMJE)
- 11. Is the WHO Trial Registration Data Set available in English?
- 12. Can registrants submit a trial for registration at any time of day on any day of the week (24 hours a day, seven days a week)?
- 13. Can the register be searched at any time of day on any day of the week (24 hours a day, seven days a week)?
- 14. It is desirable that the WHO Trial Registration Data Set be available in the language/s of the countries served by the registry. Please indicate the languages in which the registered information is displayed.
English. We have been considering expanding to include French and Portuguese to cater for all countries on the continent, but this will have to take place in our next phase of development.
- 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
- 15. What quality control measures does the registry have in place to make sure that all items in the WHO Trial Registration Data Set are as complete and accurate as possible?
The registry team reads through all applications and ensures that all incomplete information is followed up and completed before the trial is reviewed to be assigned a trial number.
- 16. Does the Registry have processes in place to prevent the registration of a single trial more than once on their register?
- 16.1. Please briefly describe these processes.
- 17. Does the Registry agree to facilitate the retrospective linking (or bridging) on the WHO Search Portal of a single trial registered with more than one registry by encouraging Responsible Registrants to enter secondary identifiers, including the UTN?
- 18. Does the Registry agree, as part of the registration process, to search the WHO Search Portal to ascertain if the trial has already been registered on another WHO Primary Registry?
- 19. Does the Registry agree to submit the WHO Trial Registration Data Set for all records on their registry to the Central Repository?
- 19.1. Is the registry regularly submitting data to the ICTRP?
Our IT design team has been liaising with WHO to create a data transfer file – the development of this file has been contracted and is slated to be completed and data transfer to take place before the close of 2010.
- 20. Does the Registry have access to a database that is used to store and manage the submitted data?
- 20.1. If not, please provide details of the database that will be used and where it is based.
- 21. Does the Registry have access to adequate information technology support?
- 22. Does the Registry have adequate security and other provisions against data corruption/loss?
Administration and Governance
- 23. Does the Registry have at least a national remit?
- 23.1. From which countries does the Registry have the remit to act as their Primary Registry?
Within South Africa, there is a National Clinical Trials Registry (SANCTR) which provides the details of all relevant trials to the ATM on a quarterly basis. However the SANCTR is not a primary register and we are the only potential primary register in South Africa.
All countries in Africa that participate in the African Vaccine Regulatory Forum have agreed to use the PACTR as their primary register.
- 24. Does the Registry have a letter of support from the relevant Ministry of Health or other agency?
- 24.1. Please specify the names of the government agencies that have given their support.
The National Department of Health has provided a letter agreeing to provide quarterly trial data to be uploaded to the PACTR.
The African Vaccine Regulatory Forum (AVAREF), which consists of the National Regulatory Authorities and National Ethics Committees from 19 countries across Africa, supports the PACT Registry to become the principal register for all clinical trials conducted in Africa. At their fourth meeting (held in Abuja, Nigeria, September 21 – 25, 2009), AVAREF members proposed to pilot legislation that would mandate registration in the Pan African Clinical Trial Registry (PACTR) (or another appropriate primary registry in the event that the trial was also being conducted in another country). At the Third AVAREF meeting it was suggested that the PACTR (previously ATM registry) become a WHO Primary Registry for the continent. This and other recommendations are the subject of a concept paper written for AVAREF and WHO by the task team on integration of ethical review, regulation and registration of clinical trials in Africa.
Member Countries of the AVAREF: Botswana, Burkina Faso, Cameroon, Ethiopia, Gabon, Gambia, Ghana, Kenya, Malawi, Mali, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.
Support for the PACT Registry as a Primary Registry for Africa also comes from the European & Developing Countries Clinical Trials Partnership (EDCTP, http://www.edctp.org. EDCTP has supported the PACTR throughout, and most recently in its primary status announcement by providing us the opportunity to present a plenary session at their Fifth Annual forum (Arusha, Tanzania, October 12 – 14, 2009).
- 25. Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- 25.1. Please indicate the web address where this information is displayed.
- 26. Is the Registry managed by a not-for-profit agency? (ICMJE)
- 27. Should the register cease to function, does the register agree that at least the WHO Trial Registration Data Set for all trial records will be transferred to a WHO Primary Register?
- 27.1. Does the registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a WHO Primary Registry?
- 28. It is desirable that Primary Registries have a strategy in place addressing the medium to long term sustainability of the registry. Does the Registry have such a strategy in place?
- 29. Other Governance information:
- 29.1. What is the name of the agency (or agencies) that fund the registry?
European and Developing Countries Clinical Trials Registry (EDCTP)
- 29.2. What is the name of the agency that manages the registry?
South African Cochrane Centre (SACC)
- 29.3. Is the agency that manages the registry a for-profit agency?
- 29.4. If the agency is for-profit, is the data on the register (database) also available on a Registry that is managed by a not-for-profit agency?
- 29.5. If the answer to 29.4 is "yes", then please specify the name of the additional Registry.
- 29.6. Please describe any other ownership or governance issues of relevance to the register. (eg Does the register have an Advisory Board. If so, what is its role?
The registry has a Working Group and an Advisory Group.
The Working Group is the “engine” of the project and executes the day-to-day processes and tasks required to meet the project objectives. The Working Group meets monthly by teleconference, and the meetings are facilitated by the Project Manager.
The Advisory Group guides and directs the project and ensures that the project remains true to its desired mission, while incorporating and adapting to regional and global trends in clinical trial registration. It meets quarterly.