FREQUENT QUESTIONS ABOUT REPEC
- What information does REPEC contain?
REPEC contains information on all the clinical trials evaluated by INS OGITT which have been authorized or non-authorized to be conducted in our country as from 2007.
- What is REPEC useful for?
• Ensures that the data and general information of clinical trials authorized to be conducted in our country is available to all citizens.
• It guarantees quality information for subjects who participate in those researches.
• It provides detailed information from several clinical trials conducted in our country, in order to have a better control of them, by providing researched scientific aspects and by allowing to covering the needs of our population on this issue.
• It supports the reliability of results by permanently checking the registry information and the development of the authorized clinical trials.
- Who can access REPEC?
All citizens can access the information contained in REPEC freely and without charge; it is publicly accessible and its use is free of any type of restriction.
- Which studies should be registered in REPEC?
All the Clinical Trials that will be conducted in our country shall be prospectively registered, under the definitions and conditions for this type of study, indicated in the Clinical Trials Regulations.
- A started or completed study, or an enrollment-closed study, can be registered in REPEC?
No, studies should be registered before they start, that means, prospectively. Applicants should take into account that after the registration, the study will be evaluated by INS OGITT, and the Clinical Trial conduction will not be able to start until it is appropriately authorized, regardless of the approval of the corresponding Ethics Committee.
- How can I access REPEC’s search engine?
REPEC is an information system composed by a database containing registered clinical trials and a public search engine of studies through which any person can make specific searches, allowing information searches by introducing keywords or clinical trials titles, and by filtering the authorization year and/or specialty. To access the search engine, click HERE, a list of coincidences in the search will appear and you can specifically select the required clinical trial.
- Can I download information from REPEC?
The results from a search can be printed using the print option at the bottom of the window, or they can be saved in PDF format (enabled by Chrome). In addition, the results can be directly copied too.
- Who is responsible for the quality, accuracy and veracity of the information contained in REPEC?
The Sponsor is the one who enters the initial information about the study and who will be responsible for the quality, accuracy and veracity of the information included in REPEC. OGITT is only responsible for the update of specific information and information subject to change related to the Clinical Trial.
- How do I register a study in REPEC and what information is required?
The registration application process is described in “Clinical Trial Registration Process”. Go to REPEC homepage to access and obtain detailed information of the steps to be followed; registration (step 1); fill the Clinical Trial data sheet with all the information requested, in Spanish and English (step 2). In this step, minutely review if the information registered in the form is correct, and if it complies with all the requirements indicated in the Clinical Trials Regulations. Finally, all the documents for the Clinical Trial Authorization should be submitted (step 3). The authorization application can be entered, as well as other procedures related to clinical trials conducted in the country.
- What happens if the information is not completed in a single session?
You can save your application and return to it later. Take into account that the entered information is only active during 7 days if your registration is not completed.