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:

1. 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.
2. 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-DIIS-028.

Complete the clinical trial data sheet}

A clinical trial registration is conducted by completing the clinical trial data sheet FOR-DIIS-028, in Spanish and English, available in REPEC.

It should be authenticated at https://repec.ins.gob.pe/

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.

Requirements:

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:

1. 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).
2. Copy of the Certification of Registration before INS for each trial site proposed.
3. 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.
4. Copy of the Research Protocol, Spanish and original language, if different from Spanish, as per Annex 5 (02 copies of each version).
5. 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).
6. 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.
7. 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.
8. 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.
9. Clinical Trial Budget as per Annex 8 of the Procedure Manual.
10. Copy of valid Insurance Policy (complete document) covering the clinical trial related damages to the research subject.
11. 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.
12. List of Supplies needed for the conduction of the clinical trial, as per Annex 10 of the Procedure Manual.
13. 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.
14. 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.

IMPORTANT:

There are important considerations to take into account for the authorization.

1. Pursuant to the Procedure Manual of Clinical Trials in Peru: MAPRO·INS-001-V.02. (2012), all informed consent forms should include the following updated paragraph with the current telephone number of INS: “If you consider that your rights are damaged or if you have any complaint, you may contact the National Health Institute (Research and Technological Transfer General Office, OGITT), entity in charge of regulating clinical trials, to the telephone 7481111 extension 2191 or you can write to the following e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.; likewise, you can submit a formal document to the INS front desk or visit OGITT at Capac Yupanqui 1400, Jesus Maria, Lima 11”.
2. 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.
3. 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:

1. 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.
2. The meetings will be requested by means of a written document sent to Director of OGITT.
3. 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.
4. 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).

QUERIES

If you need more information, contact: This email address is being protected from spambots. You need JavaScript enabled to view it..

To request a meeting, or if your query cannot be resolved by e-mail, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.  and indicate:

• 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.

In case the initially scheduled period of an authorized clinical trial needs to be extended, the Sponsor or Contracted Research Organization should request the National Health Institute an extension of the corresponding period 30 days before expiration. This authorization will not exceed 12 months and is granted by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Extension Request (Enter the data according to the e-form available in REPEC, by using your assigned user account and password assigned HERE and attach the printed form)
2. Report explaining the reasons for the extension request. (Enter the data according to the e-form available in REPEC and attach the printed form)
3. Extension approval issued by the research institution(s) where the clinical trial is conducted
4. Extension approval issued by the Institutional Research Ethics Committee registered in the National Health Institute which evaluated the clinical trial.
5. Additional List of Supplies necessary for the execution of the clinical trial (printed and electronic version) as per Annex 10, if required
6. Procedure’s receipt of payment issued by the National Health Institute’s checkout.

Frequently Asked Questions

When an extension should be requested?
The Sponsor or CRO should consider submitting a clinical trial extension request in case the project period has expired.

In case a new research site has to be included in an authorized clinical trial, the Sponsor or Contracted Research Organization should request the National Health Institute a Research Site Expansion.

This authorization is granted by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Addition of new research sites request Request (Enter the data according to the e-form available in REPEC, by using your assigned user account and password assigned HERE and attach the printed form).
2. Authorization issued by the additional research Institutions(s) where the clinical trial will be conducted.
3. Report explaining the reasons for the research site expansion (Enter the data according to the e-form available in REPEC)
4. Research protocol and/or Informed Consent Amendment Approval issued by an Institutional Research Ethics Committee registered in the National Health Institute, for the additional research site.
5. Affidavit,signed by the Sponsor and Principal Investigator Principal about the additional research site Affidavit, out as per Annex 14 of the Procedures Manual (Fitting out in Annex 3 of the Clinical Trials Regulation).
6. Additional List of Supplies necessary for the execution of the clinical trial (printed and electronic version) as per Annex 10, if required
7. Short descriptive Curriculum Vitae of the Principal Investigator(s) and Co-investigator(s).
   • Updated and signed. Indicate prior experience in Research, especially in Clinical Trials, indicating studies titles, protocol code and position performed
   • Copy of Good Clinical Practices training certificate should be attached for each Investigator (principal and co-investigators)
8. Procedure’s receipt of payment issued by the National Health Institute’s checkout for each additional research site.

In case an authorized clinical trial needs to extend or modify the list of supplies, the Sponsor or Contracted Research Organization should request the National Health Institute the Extension or Amendment of the List of Supplies

Procedure’s duration: 

Requirements

1. Request for Extension or Amendment of List of Supplies (Enter the data according to the e-form in REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining the reasons for the Request for Extension or Amendment of List of Supplies. (Enter the data according to the e-form available in REPEC).
3. Additional List of Supplies necessary for the execution of the clinical trial (printed and electronic version) as per Annex 10, if required.

Requisitos

1. Solicitud de Ampliación o Modificación del Listado de Suministros (Ingresar los datos según el formato electrónico disponible en REPEC, usando el nombre y contraseña de usuario asignado AQUI y adjuntar el formato impreso).
2. Informe justificando los motivos de la ampliación o modificación del listado de suministros. (Ingresar los datos según el formato electrónico disponible en REPEC).
3. Listado detallado adicional o modificado de suministros necesarios para la ejecución del ensayo clínico (versión escrita), según lo establecido en el anexo 10.

Important:

1. When a request for Extension / Amendment of List of Supplies is submitted the provider who will procure the supplies must be defined.
2. If new supplies are included, Annex 10 should indicate these new products, and those supplies which were previously requested and authorized should not be repeated.
3. The quantities required in Annex 10 should be explained, considering the trial duration time, number of patients to be enrolled, number of research sites, number of dose per patient, reserve stock, product expiration date, among others.
4. The parameters considered for the calculation of safety stock or reserve stock should be clearly explained.
5. If there is a mistake in a request for Extension / Modification of List of Supply by the Sponsor or CRO, a new request should be submitted in order to create a new file

In case an authorized clinical trial needs to change the Principal Investigator, the requirements indicated in this page should be attached to the request.

This authorization is granted by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Communication the Change of Principal Investigator. (Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining the reasons for the change of Principal Investigator. (Enter the data according to the e-form in the REPEC).
3. Resignation letter by previous Principal Investigator.
4. Acceptance Letter by new Principal Investigator.
5. Copy of the Letter of Acknowledgement by Institutional Research Ethics Committee which approved the study, if the Principal Investigator has been acknowledged.
6. Short Descriptive Curriculum Vitae of the new Principal Investigator.
7. Updated and signed. Indicate prior experience in Research, especially in Clinical Trials, indicating studies titles, protocol code and position performed.
8. Copy of Good Clinical Practices training certificate should be attached for each Investigator (principal and co-investigators)

In case an authorized clinical trial needs to change the Sponsor, the new Sponsor should be introduced and the requirements indicated in this page should be attached to the request.

This authorization is granted by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Letter communicating the Change of Sponsor. (Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining the reasons for the change of Sponsor. (Enter the data according to the e-form in the REPEC).
3. Letter of resignation by the previous Sponsor.
4. Letter of acceptance by the new Sponsor.
5. Copy of the Letter of Acknowledgement by the Research Institutional Ethics Committee which approved the study, if the Sponsor has been acknowledged.

Important:
- For this procedure, the new Sponsor is required to be previously registered in REPEC.
- Information about the procedure to request the registration of a sponsor Is available HERE.

The Closure of a Clinical Trial Research Site should be requested when all the activities of a research site are cancelled in advanced (for any reason upon request of the Sponsor or as a safety measure) (Art. 7, Number 4, Clinical Trials Regulation).

This authorization is granted by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Research Site Closure Request (Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining the reasons for the research site(s) closure request, including the data obtained to the date, and the measures that will be adopted with the research subjects.

Important:

If all the activities of a clinical trial in a research site are terminated in advance, besides requesting the Closure of Research Site, the Sponsor should send the research site’s final report. For this purpose, it should provide the information requested in the e-form available in the Peruvian Clinical Trials Registry (REPEC), and submit the printed version of the same in Documentary Procedure Office of National Health Institute.

Frequently Asked Questions

1. What procedure should be followed if the activities of a clinical trial are terminated in advance in all the authorized research sites and not in a single site? The closure procedure should be followed for each research site?
   If all the activities of a clinical trial are terminated in advance, a Notification for Early Termination of Clinical Trial should be done
2. When is it correct to request the closure of a research site?
   In case all activities in the research site, related to the clinical trial, have finished in accordance with the protocol, the request for the closure of a research site would not apply. Instead, the research site final report should be sent by means of the e-form available in REPEC. With this procedure, the clinical trial status for such research site would be Finished.

For any authorized clinical trial that due to any reason is (temporarily) stopped, the Sponsor or Contracted Research Organization will request the Clinical Trial Suspension to the National Health Institute.

This authorization is given by means of a Board Resolution issued by the National Health Institute

Procedure’s duration: 

Requirements

1. Clinical Trial Suspension Request. (Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining the clinical trial suspension request and including the data obtained until the suspension and the measures adopted for research subjects.

The notification for Clinical Trial Advanced Termination should be sent when all the activities of a research site are cancelled in advanced (for any reason upon request by the Sponsor, by the OGITT or the Research Ethics Committee) (Art. 7, Number 4, Clinical Trials Regulation).

This authorization is given by means of a Board Resolution issued by the National Health Institute.

Procedure’s duration: 

Requirements

1. Notification of Clinical Trial Advanced Termination sent to the General Director of Research and Technological Transfer General Office (OGITT) of National Health Institute.
2. Report explaining the clinical trial advanced termination and including the data obtained until the suspension and the measures adopted for research subjects.

Important:

If all the activities of a clinical trial in a research site are terminated in advance, the Sponsor should also send the corresponding final reports.

For any authorized clinical trial which original protocol is amended, including change of Clinical Trial’s Title, the Sponsor or Contracted Research Organization should request the authorization of amendment to the National Health Institute. This authorization is given by means of a Board Resolution.

Procedure’s duration: 

Requirement

1. Amendment Request (Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form).
2. Report explaining and detailing the change to the clinical trial title (Enter the data according to the e-form in the REPEC).
3. Research protocol Amendment Approval by a Research Institutional Ethics Committee registered in the National Health Institute.
4. Receipt of payment for procedure fees issued by the National Health Institute’s checkout.

For any authorized clinical trial that requires an amendment to the original protocol and/or informed consent forms which do not include Clinical Trial’s Title, The Sponsor or Contracted Research Organization must apply the clinical trial amendment report.

This authorization is granted by means of an Official Letter issued by OGITT

Procedure’s duration: 

Requirements

1. Amendment Report request, including the list of documents to be amended (document, version and date): Enter the data according to the e-form in the REPEC, by using your assigned user account and password HERE and attach the printed form.
2. Report explaining the amendment proposed for the clinical trial. It should contain:
   • List of the changes to the protocol / informed consent forms
   • Rationale of proposed changes.
3. Protocol and/or informed consent with highlighted changes or with track changes, in Spanish and original language, if different from Spanish.
4. Protocol and/or consent(s) with amendment included, in Spanish and English.
5. Approval of Amendment to research protocol and/or Informed Consent issued by the Institutional Research Ethics Committee registered in the National Health Institute.

Important:

• The Amendments to Research Protocol proceed only after authorization by OGITT / INS
• OGITT will not authorize Amendment modifying the original objectives of Protocol, treatment time and research product(s).

Progress reports will be submitted by the Sponsor or Contracted Research Organizations to National Health Institute (INS) for each authorized Research Site and pursuant to the e-form available in REPEC. This report will be submitted on a quarterly or half yearly basis as from the issuance date of the Clinical Trial Authorization Resolution.

Requirements

• Send to INS as per the e-form available in REPEC, by using the user account and password assigned HERE and attach the printed form. This report should be submitted by means of the Documentary Procedure Office of INS

Each Progress Report should be submitted with its corresponding file and by separate.

Important:

1. The following information must be included in the Clinical Trial Progress Report:
   • No. of Subjects who failed the screening (screen failure): This number is deduced from the subtraction between screened patients and enrolled patients.
   • No. of subjects with clinical failure: Those patients who entered to the study and were considered as non-responsive to the prescribed treatment or who worsened their condition.
   • Serious Adverse Events (SAEs): In addition to the number of SAEs in item 5, a summary table of serious, expected and unexpected adverse events notified to the date should be attached; it is created by REAS-Net System. This table should indicate:
     - Patient Identification Code, Serious Adverse Event, Occurrence date, date of notification to the National Health Institute, SAE outcome*, relation to the research product. Indicate if the SAE was expected or unexpected.
     - *SAE’s outcome: Completely recovered, Recovered with sequel. Improved condition, Unchanged and still present condition, Worsened condition, Death.
   • Non Serious Adverse Events: The Non Serious Adverse Events table, Item 4, should be submitted separately in a digital format (CD).
2. The following should be attached to the Progress Report:
   1. Quarterly or Half-yearly Report of Deviations/Breaches to the Protocol of every research sites occurred in the indicated term. The following information should be indicated at least: patient’s identification code, date of deviation (dd/mm/yyyy), deviation description, type of deviation (numeric code can be used*), corrective measure taken and its reasons, date of corrective measure enforcement (dd/mm/yyyy), date of notification to the ethics committee (dd/mm/yyyy). This information can be sent in the Sponsor’s format.
   2. Quarterly or Half-yearly Report of the Serious and Unexpected Adverse Reactions related to the research product, occurred abroad. This is a written summary list of the SUSARs reports, occurred in the period indicated, which includes at least the following information: No. of Protocol involved, No. of Notification, date of notification, type of report, country of origin, participant’s code, age, sex, SAE’s description, date of start/end, suspected product (dose, frequency, route), outcome, causality. The Sponsor should submit an evaluation of the research product safety profile and the risk-benefit balance in order to continue the study. The list and each report should be sent in digital format (CD).

*TYPE OF DEVIATIONS

1. Procedures related to the IC
2. Inclusion/Exclusion criteria
3. Study drug/dosage
4. Evaluations and/or lab procedures required in the study
5. Study procedures
6. Serious Adverse events/device adverse effects report
7. Randomization procedures
8. Program and/or visit interval
9. A deviation that affects the efficacy valuation
10. Concomitant therapy
11. Others

Frequently Asked Questions

1. How should a Progress Report be submitted?
   The Sponsor or CRO should consider the following recommendations when submitting a progress report:
   a. Submit the progress reports of all the research sites participating in the clinical trial, including even those which may have not enrolled any patient.
   b. Strictly follow the indications of the Progress Report form, Annex 12 of the Procedures Manual published in the website of National Health Institute.
2. When should a progress report be submitted?
   The progress report submission term is indicated in the Board Resolution that authorized the clinical trial execution in the country. Time is counted since the date of issuance of such resolution. Therefore, the progress report submission should be carried out for all the research sites even those extended after the clinical trial authorization.
3. What is the meaning of each item in the research subject progress report in relation to the research subjects?
   • No. of Screened Patients, No. of Enrolled patients, No. of Active patients, No. of Withdrawn patients, No. of Patients who completed the study, No. of Patients with clinical failure, No. of pending enrolment patients.
   • Screened Patients: Selected patients who, after signing the Informed Consent, are submitted to a series of analysis and visits to determine if they comply with the inclusion criteria and who not necessarily will be enrolled or randomized.
   • Enrolled patients: Patients who, after signing the informed consent and gone through analysis and visits, comply with the inclusion criteria and finally enter into the study and are randomized to participate in one of the arms as per the study design.
   • Active patients: Patients who, after randomization, receive treatment (research product or placebo).
   • Withdrawn patients: Patients who are withdrawn by Investigator’s or Sponsor’s decision, or who leave the study by their own decision.
   • Patients who completed the study: Patients who complete the study drug stage and who also have a final follow up visit.
   • Patients with clinical failure: Patients who entered the study but were considered as non-responsive to the prescribed treatment or whose condition worsened.
   • Pending enrolment patients: Number of patients who should be enrolled, in accordance with the assignation for our country before the beginning of the study, pursuant to the number of sites. The Sponsor or CRO should divide the number of patients by country and then by site. For example, if there are 10 sites in Peru, where 100 patients are planned to be enrolled, then each site should include 10 patients, and if at the moment of submitting the progress report of a site, this has only enrolled 6 patients, there would be 4 patients pending for enrolment in such site.
4. How do I indicate the number of patients with screening failure?
   This number of patients is deductible from the screened patients minus enrolled patients.

1. Research Site Final Report
   Once the Clinical Trial is completed, the Sponsor or Contracted Research Organization will immediately send the final report of each research site to OGITT, in a maximum term of thirty (30) calendar days after the Closure Visit conducted by the monitor.
   Requirements
   Send INS as per e-form available in REPEC, using the user account and password assigned HERE and attach the printed form. This report should be submitted by means of the Documentary Procedure Office of INS.
   Each final report should be submitted in its corresponding file and by separate.
2. National Final Report
   Once the clinical trial of all research sites nationwide is completed, the Sponsor or Contracted Research Organization will send the National Final Report in a maximum term of sixty (60) calendars days after the final report of the last research site
   Requirements
   Send INS as per e-form available in REPEC, using the user account and password assigned HERE and attach the printed form. This report should be submitted by means of the Documentary Procedure Office of INS
3. International Final Report
   Once the Clinical Trial is completed, the Sponsor or Contracted Research Organization will send the International Final Report, in a maximum term of twelve (12) months after the finalization of the clinical trial in all the research sites worldwide.
   Requirements
   - Send INS as per e-form available in REPEC, using the user account and password assigned HERE and attach the printed form. This report should be submitted by means of the Documentary Procedure Office of INS
   - The International Final Report should include the final results and the study conclusions before publication.

Serious Adverse Events and Unexpected Adverse Reactions occurred in the country should be notified to the Research and Technological Transfer General Office (OGITT) of National Health Institute via REAS-NET. To fill the data serious adverse events report in REAS-NET system, follow the Instructions available in the Procedure Manual for the conduction of clinical trials in Peru (Annex 11)

All the Serious Adverse Events (related or not) should be notified to INS by the Sponsor in a maximum term of 7 days as from the occurrence or acknowledgement of the event (Art. 109, paragraph a, from Supreme Decree 017-2006-SA), otherwise it would be considered an infraction (art 131, paragraph f from the Amendment, from Supreme Decree 006-2007-SA) subject to sanction (Chapter II, title XII Art. 132 from Supreme Decree 017-2006-SA).

Requirements

1. All the serious adverse events (related or not) and unexpected adverse reactions should be sent in a maximum term of seven (07) days, as from the occurrence or acknowledgement of the event (Enter the data according to the e-form available in REAS-NET, using your assigned user account and password and attach the printed form. This report should be submitted by means of the Documentary Procedure Office of INS.
2. Complete the previous information within the following eight (08) days; otherwise, you should submit update reports. Once you complete the follow up, send the final report via REAS-NET, and after the blind is opened, if appropriate.

Frequent mistakes

• What are the most frequent mistakes when filling the Report of Serious Adverse Events in Clinical Trials?
  1. Incomplete or mistaken data about the trial, which makes difficult to identify it: Please, verify the Protocol Code is indicated, as well as the Authorization Resolution and date.
  2. Incomplete information about the SAE: Report the patient code without changes; do not add more numbers or letters; indicate the SAE start date. Provide an accurate description of the SAE; for instance, do not indicate abdominal pain instead of the real cause: hemorrhagic pancreatitis; cardio-respiratory infarction instead of disease progression. In order to uniform terms, the WHO Adverse Reactions Terminology Dictionary or MedDRA should be used. Make a complete summary of the serious adverse event and complete the information with follow up and final reports, if applicable. Report the event outcome and the recovery date or event termination.
  3. Missing information about the research product: Indicate the administered research product(s) and indicate the suspect product (which could be the concomitant drug); likewise, indicate the measures taken in relation with the research product, especially if it was temporarily interrupted or it was definitively terminated and indicate what happens when the research product is interrupted, when the dose is reduced and when it is administered again (re-exposure). Besides, indicate if there was lack of adherence to the treatment or if it was a medication mistake.
  4. Missing information about the measures taken for the research subject: Specify the support therapy or drug therapy in an additional sheet; do not indicate it in the space for concomitant drug.
  5. Missing information about the concomitant drug: Treatment start and termination dates are important as well as comments in case you consider the adverse event is caused by a concomitant drug.
  6. Missing information in the clinical chart summary: Report the complete medical background, i.e., the co-existing medical conditions related to the adverse event.
  7. Missing information about auxiliary laboratory tests: They can be provided in a separate sheet, indicating the normal or baseline values and including your comments about the results of the laboratory tests or other diagnosis tests which support the causality.
  8. Prevent Duplicity of reports and contradictions between initial and final report. Likewise, do not fill in the form by hand.

*Each procedure related to Clinical Trials should be submitted in its corresponding file and by separate.

ADDITIONAL CONSIDERATIONS:

• All the corresponding items in the Report Form of Serious Adverse Events should be filled with complete information and in chronological order, to make it easier to understand. Use the correct term to indicate the SAE; we recommend checking the terms in the WHO Adverse Reactions Terminology Dictionary (WHO-ART) included in the system.
• Serious and unexpected adverse events reports, suspected to be related to the research product (SUSARs), occurred in the country, should be reported as soon as possible, by written in CIOMS form and in digital form (CD)
• The Sponsor or CRO will send quarterly or half-yearly a printed summary in Excel of serious and unexpected adverse reactions, occurred in the authorized clinical trial, other clinical trials with the same research product or in a different use context. Likewise, CIOMS reports of international serious and unexpected adverse reactions should be sent in digital form together with the printed Excel version.
• The sponsor should send as soon as possible, in CIOMS form, the SUSARs Reports occurred abroad, to the investigator, and through him, it will be sent to the Institutional Research Ethics Committee (CIEI)
• Other adverse events described in the Investigator’s Brochure should be notified or reported in accordance with the procedures described in the Procedure Manual for the conduction of Clinical Trials in Peru.
• Any expedite safety report, about any event threatening the safety of study participants and/or alters the risk/benefit of the study should be sent separately as soon as possible, in accordance to the Clinical Trials Regulation, Supreme Decree No. 017-2006-SA, Article 107 paragraph d) “...In case of a relevant safety problem, a report will be prepared separately without prejudice of the periodicity mentioned in Chapter II herein, and will be sent to the Health National Institute and to the corresponding Research Ethics Committee in a maximum term of seven working days”.

NOTE: Non Serious Adverse Events related to the research product will be notified to the Research and Technological Transfer General Office (OGITT) of National Health Institute along with the corresponding progress report in digital version.

The annual update report should include:

• Summary of changes, Spanish and English version
• Investigator’s Brochure with the amendment included, English and Spanish version (changes made should be highlighted).