What does registration mean in clinical trials?
Registrational Trial means a Clinical Trial that is designed to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).
What is the difference between a registry and a clinical trial?
There is only one difference between registry studies and clinical trials: registry studies are observational, they look backwards at what was done without dictating a treatment plan. Clinical trials are investigational, they look forward to what shall be done and dictate and control the treatment plan.
Why clinical trial registration is required?
Clinical trial registration in advance has numerous benefits as it eludes the risk of trials to be replicated needlessly, and also allows the members of the community having specific health issues to recognize the specific trials in which they can take part.
What is a registration study?
Registration Study means a Clinical Trial that is intended (as of the time the Clinical Trial is initiated) to obtain sufficient data and results to support the filing of an application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).
How many clinical trial registries are there?
Eight registries (ANZCTR, ChiCTR, CTG, DRKS, IRCT, ISRCTN, JPRN, and SLCTR) allow trial registrations from all countries, and the rest usually from the country where the registry is based, or from specific countries or regions.
Why do we study register?
Why is study registration important? At its heart is a simple idea: that all studies should be registered in publicly accessible places. The reasons for this span ethical, moral, accountability, research integrity and waste reduction perspectives.
What are the regulatory requirements for clinical trials?
Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements. It has 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee (EC) approval templates and a format for serious adverse event (SAE) reporting.
What is a register in research?
Research registers may be regional, national or international registers of ongoing and completed research. They may record clinical trials as well as research conducted using other study designs.