Frequently Asked Questions
● What is a clinical trial?
For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.
● Which trials should be registered?
All clinical trials should be registered. Thus, early and late trials, trials of marketed or non-marketed products, randomized or non-randomized trials -- all should be registered.
● What is the difference between a clinical trials register and a clinical trials registry?
A clinical trials register is the formal record of an internationally agreed minimum amount of information about a clinical trial. This record is usually stored in and managed using a database. A clinical trials registry is the entity that houses the register, and is responsible for ensuring the completeness and accuracy of the information it contains, and that the registered information is used to inform health care decision making. A clinical trials registry is more than its database.
● Why register clinical trials?
The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility because:
● Who is responsible for registering a trial?
An appropriate representative of the trial’s primary Sponsor. The Responsible Registrant is responsible for ensuring that the trial is properly registered. The primary Sponsor may or may not be the primary funder. The responsible registrant should make every reasonable effort to ensure that a trial is registered once and only once in any one register, and that the trial is registered in the fewest number of registers necessary to meet applicable regulations.
● When should trials be registered?
Trials should be registered before the first participant is recruited.
● Can I register with the WHO ICTRP?
No, WHO does not maintain its own registry so you cannot register your trial directly with WHO ICTRP.
● What information needs to be registered?
The minimum information that must be registered is specified in the WHO Trial Registration Data Set. Individual registers may request more information than this.
● Are there software or hardware specifications that should be followed for building a trial registry?
Yes, please contact WHO ICTRP.
● How many times should a trial be registered?
To meet WHO requirements for transparency and publication it is only necessary for your trial to be to registered once, in either a Primary Registry or an ICMJE approved registry.
● How do I cite a record on a clinical trials register?
Please read this document (https://cdn.who.int/media/docs/default-source/documents/health-topics/how-to-cite.pdf?sfvrsn=d027a259_2).
● When to cite a record on a clinical trials register?
The registry record will be the only publicly available document on a trial until results from the trial are published. Some examples of situations when studies might be quoted are:
● What is trial registration?
WHO regards trial registration as the publication of an internationally-agreed set of information about the design, conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.
What is the ICTRP?
The ICTRP is a global initiative that aims to make information about all clinical trials involving humans publicly available. It also aims to: