The clinical trial registration is prospective and is one of the requirements to be complied with to obtain the authorization for the conduction of a clinical trial in Peru.
To register a clinical trial, the Sponsor or its legally authorized representative in the country shall access the Peruvian Clinical Trials Registry (REPEC) by entering its user and password. Sign in here.
To obtain a user account the following is required:
- The Sponsor and Contract Research Organization (CRO) working on its behalf should be previously registered as such in REPEC.
- To obtain information about the Sponsor Registration procedure, click here.
- To obtain information about the CRO Registration procedure, click here.
- Once the Sponsor or CRO are duly registered, the user account and password are easily generated from here:
Clinical Trial Registration and Application for Authorization FOR-OGITT-028.
A clinical trial registration is conducted by completing the clinical trial data sheet FOR-OGITT-028, in Spanish and English, available in REPEC.
It should be authenticated at http://www.ins.gob.pe/ensayosclinicos.
You could submit your applications for authorization and other procedures related to clinical trials conducted in the country.
Before any procedure, minutely review if the information entered in the form is updated and correct, and if the procedure to be started complies with the requirements indicated in Article 66° of the Clinical Trials Regulation in Peru. This will prevent delays and annulments, and will allow offering a prompt and efficient service.
For instructions on how to fill the data sheet, click here.
Every clinical trial to be executed within the national territory should be delivered for evaluation to the General Office for Research and Technology Transfer of the National Institute of Health (INS). If the regulation in force (DS017-2006 SA: Clinical Trial Regulation in Peru) is technically and administrative complied with, the execution is authorized by means of a Directorial Resolution.
The requirements are indicated in Article 66° of the Regulations in force and in the Procedure Manual, MAPRO·INS-001-V.02.
Take into account the following list, since it contains updated and detailed information for each requirement:
- Application for Clinical Trial Authorization along with the certification of registration as authorized trial site to conduct clinical trials. (Enter the data according to the e-form in the Peruvian Clinical Trials Registry, using the assigned user account and password and attach the printed form).
- Copy of the Certification of Registration before INS for each trial site proposed.
- Copy of the Document of Approval by the maximum authority of the Research Institution where the clinical trial will be conducted, which does not exempt them from the responsibilities set forth by Law.
- Copy of the Research Protocol, Spanish and original language, if different from Spanish, as per Annex 5 (02 copies of each version).
- Copy of the Informed Consent Form(s) from each trial site, sealed and certified by an Ethics Committee registered in INS (as per Annex 8 of the Clinical Trials Regulation in Peru).
- Copy of the Document of Research Protocol Approval and the Informed Consent Form issued by an Institutional Research Ethics Committee registered in the National Institute of Health.
- Updated Investigator’s Brochure (version not older than 01 year at the time of application), in Spanish and original language (if different from Spanish) as per Annex 2 of Clinical Trials Regulation in Peru / Annex 06 of Procedure Manual (02 copies for each version). For investigational product with sanitary registration in the country, and if the research product is used under the conditions authorized by DIGEMID, the Investigator’s Brochure may be replaced by the authorized insert.
- Affidavit, signed by the executing organization/institution and the principal investigator, stating that there is no conflict of financial interest in the execution of the clinical trial, as per Annex 7 of the Procedure Manual.
- Clinical Trial Budget as per Annex 8 of the Procedure Manual.
- Copy of valid Insurance Policy (complete document) covering the clinical trial related damages to the research subject.
- Regardless of the availability of an insurance policy, an affidavit guaranteeing the availability of a budget to cover possible damages as a result of the participation in the clinical trial should be submitted. This affidavit should be signed by the Sponsor and the Principal Investigator, as per Annex 9 of the Procedure Manual.
- List of Supplies needed for the conduction of the clinical trial, as per Annex 10 of the Procedure Manual.
- Short descriptive Curriculum Vitae of Principal Investigator and Co-Investigator(s).
Note: Short descriptive Curriculum Vitae should be updated and signed. Prior experience in research should be indicated, especially in clinical trials; the clinical trials titles should be indicated, as well as protocol code and position. Copies of the Good Clinical Practices training certificates for principal and co-investigators should be attached.
- Processing fee receipt for each trail site.
Duration of procedure:
- For chemically synthesized drugs: Maximum term of 40 working days (including 30 days of safety profile evaluation by DIGEMID).
- For biological drugs and controversial situations requiring the calling of technical commissions: Maximum term of 60 working days (including 45 days of safety profile evaluation by DIGEMID).
If complementary information is required from the interested party, the counting of the evaluation term will be suspended until the whole requested information is received.
Document submission instructions:
- All documents should be submitted via INS’ Documentary Procedure Office, in a ring binder, ordered pursuant to the stipulations set forth, indicating each document name by means of markers.
- All documents should be valid and updated to the date of submission.
- All documents should be submitted in Spanish. If there are documents in other language, they should be submitted in original together with the corresponding translation.
- Submit the most recent protocol version. Do not add prior amendments to the authorization request.
- For the Supply List, please indicate in the corresponding annex the number of lot or code system, which should include the corresponding code.
- Article 6° of the Clinical Trials Regulation sets forth that the General Direction of Medicines Supplies and Drugs (DIGEMID) is in charge of issuing a binding technical opinion about the safety profile of the research product based on its competence environment. In such context, attach all the additional document you may consider should be sent to DIGEMID for evaluation.
There are important considerations to take into account for the authorization.
- Complementary tests (pharmacogenetics, pharmacodynamics, pharmacokinetics or others) which require biological sample storaging and which are not included by the general study, should be part of an additional special Informed Consent.
- In case of pregnancy during the study, the informed consent should establish the immediate withdraw of the pregnant patient by describing the procedures for the follow-up and control of the same. The newborn follow up should be at least 6 months. Complete pregnancy and research product follow-up and control include the research subject’s male partner. In case clinical trials are required in pregnant patients, they should comply with the conditions set forth by Article 20° of the Clinical Trials Regulation in Peru.
Oral Presentation of Investigational Product:
- The Sponsor/CRO may consider, by their own account, during the authorization process of a clinical trial, to carry out an oral presentation of the investigational product. During these expositions, representatives of the Team of DIGEMID will be present, as well as members of reviewer team from OGITT-INS Clinical Trials Area.
- The meetings will be requested by means of a written document sent to Director of OGITT.
- Each presentation will last 20 minutes and the meetings will be scheduled subject to availability. The Sponsor/CRO will be notified about the date and time in due advance.
- Each presentation should include at least the following aspects:
- Clinical Trial Protocol Summary, indicating how the investigational product will be administered and which countries the clinical trial will be conducted in (2 slides).
- Research Product Description (physical and chemical properties, formula and dose, drug action and route of administration) (2 slides).
- Pre-Clinical Studies results (results from pharmacological safety studies, clinical findings in single- and repeated-dose toxicity studies, reproductive and developmental toxicity) (3 slides).
- Pharmacokinetic parameters shown by clinical trials (mean lifetime, AUC, Cmax, metabolism and clearance) (2 slides).
- Efficacy and safety results (performed studies, adverse events registered as per age, sex, drug dose, emphasis on events related to the research product) (3 slides).
- Meeting agenda.
- List of attendees.
- Any relevant information for the meeting.
You will receive a reply by e-mail indicating date and time for the meeting subject to availability.