Frequently asked questions
The South African Cochrane Centre (SACC), in partnership with The European and Developing Countries Clinical Trials Partnership (EDCTP) and the Cochrane Infectious Disease Group, has established an international registry for all clinical trials conducted in Africa.
The Pan African Clinical Trials Registry (PACTR) is an African initiative to support regional clinical trial registration. The PACTR is an official registry and member of the World Health Organization (WHO) Network of Primary Registers.The PACTR provides data to the central WHO International Clinical Trials Registry Platform (ICTRP), so that trials registered in the PACTR are represented in global searches (WHO ICTRP search portal URL: http://apps.who.int/trialsearch)
What are the aims of the Pan African Clinical Trials Registry?
The Registry aims to:
What does it mean to be a member of the WHO Network of Primary Registers (NPR)?
Primary registry status is granted by the WHO only to registries who meet specific criteria for content. Criteria are separated into six categories, namely, content, quality and validity, accessibility, unique identification, technical capacity and administration, and all categories must be met in order to receive primary registry status. WHO primary registries meet the requirements of the ICMJE which stipulate that in order to be published in a member-journal, registration is mandatory.
How will the information contained in the registry be useful?
The Pan African Clinical Trials Registry will be an important global resource for researchers, clinicians, policy makers and the lay public by:
What is a clinical trial?
There are many definitions of clinical trials. In general clinical trials are biomedical or health-related research studies in human beings that follow a pre-defined protocol. A clinical trial is prospective research designed to evaluate the safety and/or effectiveness of drugs, medical devices, treatments or preventive measures in humans. For more information see World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) or the Ottawa Statement
Since clinical trials have been variably defined, it is important for PACTR to clearly state what we include in our definition.
How does the PACTR define clinical trials? PACTR accepts interventional RCTs and CCTs, pharmacokinetic and pharmacodynamic studies on its registry (including phase 1 - 4 trials).
A Randomized Control Trial (RCT) is a trial in which participants are randomly allocated to one of two or more intervention arms allocating people to groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization, adaptive randomization). The control group is usually given either the standard intervention for the disease in question or a placebo while the other group (or groups) is assigned to the experimental arm(s) (drug or other intervention).
A Controlled Clinical Trials (CCT) is a trial in which participants are allocated to one of two or more intervention arms allocating people to groups using a method not based on chance (e.g., birthdate, day of the week registered, etc.). The control group is usually given either the standard intervention for the disease in question or a placebo while the other group (or groups) is assigned to the experimental arm(s) (drug or other intervention).
What does the PACTR exclude from its definition of clinical trial?
Observational studies which are studies in which individuals are observed and their outcomes are measured by the investigators.
Why is it important to register your clinical trial?
There are both ethical and scientific reasons for registering trials. People who participate in clinical trials expect their contributions to be made use of in improving health care for everyone. Open access to information about ongoing and completed trials will satisfy the ethical duty to trial participants and will promote greater trust and public confidence in clinical research. Clinical trial registration in open access registries will also reduce selective publication of trial results. In addition to this clinical trial registration will decrease wasteful duplication of research, promote international research collaboration and ensure more efficient and effective allocation of research funds.
What is a clinical trial register?
A clinical trial register is essentially a database that contains pertinent information (both administrative and scientific information) on each registered trial.
Which trials may be registered with the Pan African Clinical Trials Registry?
All clinical trials conducted in Africa may be registered in the Pan African Clinical Trials Registry. We encourage the registration of early phase trials and pilot studies.
What do I need to know before I register my trial?
If the trial is already registered with a Primary or Partner register within the WHO ICTRP Registry Network, must the trial be registered again with the Pan African Clinical Trials Registry?
If your trial is already registered with a WHO Primary Register, there is no need to register the trial again with the Pan African Clinical Trials Registry. If you have registered your trial in a registry that is not acknowledged within the WHO ICTRP Registry Network, it would be advisable to register with one of these in order to ensure that you fulfill journal requirements.
Who should register the trial?
It is recommended that the trial sponsor register the trial. However trial coordinators or principal investigators may also register the trial. For multi-site studies trial data should be submitted only once. (Do not submit trial data for each study location).
The trial registrant is responsible for:
When should a trial be registered?
Ideally, trials should be registered before the enrolment of the first participant. Trials may be registered either before or after receiving regulatory and/or ethics approval.
How do I register a trial with the Pan African Clinical Trials Registry?
(see how to register a trial page)
What information do I need to register a trial?
Your reset password will be mailed to you to the email address you provided during registration. Please go and review this email to retrieve your new password. Once you login you can navigate to the "MyProfile" page to change your password.
How can I refine a search?
A search can be refined using the advanced search option. In order to access the advanced search, first click on the search link on the homepage. From there, you will see a link to advanced search. This will allow you to refine your search options.
Why is my advanced search not working?
One reason you may be having difficulty with the advanced search function is that in order for the search to be conducted you must remember to click in the tick boxes in order for a particular field to be searched.
I submitted my application a number of days ago, why have I not heard anything back?
If your application was submitted more than a week ago and you have yet to receive any correspondence from us, then you should check two things:
Why is my data not being saved to the trial profile?
When you are navigating from page to page while filling in the data, please be sure to navigate using the next button at the bottom of the page. By hitting the next button, your data is sent through to the database and then saved. If you are navigating between pages using any other means (including the trial tracker function) then your data will not be saved.