Frequently Asked Questions
1What 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.
2What is trial registry?
WHO regards trial registry 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.
3Why is trial registry Important?
1. There is a need to ensure that decisions about health care are informed by all of the available evidence
2. It is difficult to make informed decisions if publication bias and selective reporting are present
3. The Declaration of Helsinki states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".
4. Improving awareness of similar or identical trials will make it possible for researchers and funding agencies to avoid unnecessary duplication
5. Describing clinical trials in progress can make it easier to identify gaps in clinical trials research
6. Making researchers and potential participants aware of recruiting trials may facilitate recruitment
7. Enabling researchers and health care practitioners to identify trials in which they may have an interest could result in more effective collaboration among researchers. The type of collaboration may include prospective meta-analysis
8. Registries checking data as part of the registration process may lead to improvements in the quality of clinical trials by making it possible to identify potential problems (such as problematic randomization methods) early in the research process
2. It is difficult to make informed decisions if publication bias and selective reporting are present
3. The Declaration of Helsinki states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".
4. Improving awareness of similar or identical trials will make it possible for researchers and funding agencies to avoid unnecessary duplication
5. Describing clinical trials in progress can make it easier to identify gaps in clinical trials research
6. Making researchers and potential participants aware of recruiting trials may facilitate recruitment
7. Enabling researchers and health care practitioners to identify trials in which they may have an interest could result in more effective collaboration among researchers. The type of collaboration may include prospective meta-analysis
8. Registries checking data as part of the registration process may lead to improvements in the quality of clinical trials by making it possible to identify potential problems (such as problematic randomization methods) early in the research process
4What is a Primary Registry?
Primary Registries in the WHO Registry Network meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity and administration. Primary Registries meet the requirements of the ICMJE.
5What is the Indonesia Clinical Research Registry
The INA-CRR is a web-based integrated system accessible at www.ina-crr.id that streamlines the application, review and approval process to conduct research in the MOH. Designed to simplify procedures, the system enables investigators to submit relevant documents to be reviewed by the respective authorities. INA-CRR serve as a one stop center for research application for study related to MOH specifically and also as a database for all clinical trials that are conducted in Indonesia. It is a not-for-profit Registry, with free and open access to researchers, clinicians, and the general public.
6How to Registry a Research in INA-CRR
To register your research, you need to take the following steps :
1. Get an account for your institution/organization (If your organization/institution has been registered, you may contact the assigned person).
2. After getting INA-CRR account you can complete the data set.
3. INA-CRR will review and contact you to complete the required information.
4. INA-CRR team will give you the registry number approximately 7 working days.
5. Download the guidelines for details information
1. Get an account for your institution/organization (If your organization/institution has been registered, you may contact the assigned person).
2. After getting INA-CRR account you can complete the data set.
3. INA-CRR will review and contact you to complete the required information.
4. INA-CRR team will give you the registry number approximately 7 working days.
5. Download the guidelines for details information