Inspections are official supervisions of the documents, sites, registries, files or any other relevant source related with the clinical trial that can be done to the Sponsor or CRO, Institutional Research Ethics Committees or at any other place involved in the clinical trial. These inspections can be ordinary or extraordinary.

Ordinary Inspections

The inspectors of the General Office of Research and Technology Transfer carry out routine inspections that are scheduled annually, according to the following criteria:

Clinical Trials Inspections

• Vulnerable Populations
• Phase of the Clinical Trial
• Impact of the research on public health
• Safety of the Research Product
• Type of the Research Product (Recombinant Product, Monoclonal Antibody, Cell Therapy, Gene Therapy, New Chemical Entities, Blood Products, Orphan products, among others)
• Therapeutic indication (new clinical indication of a research product, evaluation of a research product in a population not thoroughly studied in previous phases, among others).
• By request of the Clinical Trial Evaluation Team

 Research Centers Inspections

• High Subjects Recruitment.
• Researchers’ background.
• High number of Clinical Trials
• Relevant information from Safety Reports and/or Progress Reports
• History of Inspection (never inspected, long time since last inspection, previous inspection with findings)

Extraordinary Inspections

Extraordinary inspections are not scheduled but carried out in response to specific trigger elements as for example:

• A complaint received by phone (748 1111, extension 2191), by e-mail (This email address is being protected from spambots. You need JavaScript enabled to view it.) or by formal document to the National Institute of Health.
• Any relevant information received from the Safety Reports, Progress Reports and/or Notifications of Deviations.
• A request by the General Director of the General Office of Research and Technology Transfer or the Executive Direction.
• A request of the Clinical Trial Evaluation Team

Notification of the Inspections

Ordinary Inspections will be previously informed to the Sponsor or its Legal Representative or CRO, who in turn will notify the Principal Investigator responsible for conducting the clinical trial. The notification of the inspection will be made with at least two (2) business days in advance of the scheduled date in order to ensure the presence of the Principal Investigator and the Research Team, and/or the Sponsor or its Legal Representative or CRO; and to have access to the clinical trial records.

Extraordinary inspections may be carried out without the requirement of prior notification.

Classification of the Inspections findings

Findings may be classified as “minor, major or critical” in order to adopt appropriate measures to redirect violations to the ICH-GCP guideline, ethical norms and/or national Clinical Trials Regulations.

Minor findings: conditions, practices and processes that would not be expected to adversely affect the right, safety or well-being of the subjects and/or the quality and integrity of data. Minor findings reveal the need for improvement of conditions, practices and processes. These include (and are not limited to):

• Make changes to the conditions of authorization of the clinical trial or amendments to the research protocol without having been previously authorized by the regulatory authority as long as these modifications do not adversely affect the rights, safety or well-being of the subjects and / or the quality and integrity of the data.
• Conduct the clinical trial without adjusting to the content of the protocols on the basis of which the authorization was granted as long as these deviations do not adversely affect the rights, safety or welfare of the subjects and / or the quality and integrity of the data.
• Clinical trial information not recorded or handled and stored in a manner that does not allow accurate reporting, interpretation and verification as long as this information does not adversely affect the rights, safety or welfare of the subjects and / or the quality and data integrity.

Many minor findings might indicate a bad quality and the sum might be equal to a major finding with its consequences.

Major findings: conditions, practices and processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data. Major findings are serious findings and are direct violations of GCP principles. These include (and are not limited to):

• Make changes to the conditions of authorization of the clinical trial or amendments to the research protocol without having been previously authorized by the regulatory authority.
• Non-compliance with the obligation to communicate Serious Adverse Events to the General Office of Research and Technology Transfer.
• Late communication of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions occurred in Peru.
• Promotion or advertisement of the research product.
• Conduct the clinical trial without adjusting to the content of the protocols on the basis of which the authorization was granted as long as these deviations might adversely affect the rights, safety or welfare of the subjects and / or the quality and integrity of the data.
• Conduct the clinical trial without the qualifications, training and / or experience to perform the research tasks.

The sum of many major findings be equal to a critical finding with its consequences

Critical findings: conditions, practices and processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data. These include (and are not limited to):

• Use of the Research Product in participants without having the authorization of the regulatory authority.
• Conduct clinical trials without the authorization of the regulatory authority.
• Breaches of confidentiality and privacy of the research subjects.
• Non-compliance with the security measures adopted by the General Office of Research and Technology Transfer.
• Conduct clinical trials without the informed consent of the research subjects.
• Fail to provide information about the clinical trial to the research subjects.
• Conduct the clinical trial without adjusting to the content of the protocols on the basis of which the authorization was granted as long as these deviations adversely affect the rights, safety or welfare of the subjects and / or the quality and integrity of the data.
• Fabrication or falsification of information related to the clinical trial or its data.
• Prevent inspector to perform the inspections.

Serious adverse events, serious adverse reactions and suspected unexpected serious adverse reactions arising from clinical trials in Perú must be notified by the sponsor to the General Office of Research and Technological Transfer (OGITT) of the National Institute of Health (INS), in accordance with the definitions and time frames specified in Clinical Trials regulations, D.S. 021-2017-SA (art. 110, subsection a).

All serious adverse events, serious adverse reactions and suspicions of serious and suspected unexpected serius adverse reactions, must be notified by the sponsor / OIC as soon as possible, within a maximum period of seven (7) calendar days, since the sponsor becomes aware of the fact, otherwise it would be an infraction of DS 021-2017-SA (article 131, subsection e).
Enter the data electronically, through the REAS-NET database, using the electronic format FOR-OGITT-046 (Click here using the username and password). After completing the electronic form, it must be printed and sent to the INS Document Processing Office.

It will complete, if necessary, the information of the initial report, within the following eight (8) calendar days, otherwise it will send follow-up reports. After the follow-up is completed, a final report will be sent. The blind will be open if appropriate.

The following should be taken into account:

• Fill the e-form with complete data, do not leave blank spaces, and follow a chronological order in the narrative. Use the correct term to name the SAE, look up the terms in the WHO Adverse Reaction Terminology Dictionary (WHO-ART) included in the system.
• In the event that the notifier identifies wrong information in the report of serious adverse events sent through REAS-NET, the change must be requested by sending a document justifiying the reasons, through the INS Document Processing Office.
  
  
• In exceptional cases in which it is necessary to request the cancellation of the report, a document must be sent justifying the reasons, through the INS Document Processing Office.

Pregnancy Report

The principal investigator must notify the sponsor or CRO about the pregnancy of a woman under investigation or of the partner of the subject under investigation, as soon as possible within the terms established in the clinical trial regulations. The sponsor or CRO must report to OGITT / INS using the format FOR-OGITT-047 “Notification of the Pregnancy and the Newborn in Clinical Trials” (Click here) and send it in printed format and on CD through the INS Document Processing Office. This format can not be accessed through the virtual system.

Suspected Unexpected Serious Adverse Reactions (SUSAR)

The SUSARs and Serious adverse reactions that occur internationally must be notified by the sponsor or CRO to OGITT / INS, quarterly or semiannually, as appropriate. DS 021-2017-SA (article 110, subsection c). These reports in CIOMS format, must be sent on a CD that will also include a Summary List of the reports, in an Excel file and in Spanish, with a cover letter through the INS Document Processing Office. These reports should not be translated or presented in printed format and can not be sent through the virtual system.

The information that should be included in the Summary List of SUSAR reports can be found in the Safety Reports Guideline (Click here).

Safety Findings

Any finding that could adversely affect the safety of the research subjects, have an impact on the conduct of the study or alter the benefit / risk balance, should be reported through an expedited safety report. It can be any event that threatens the safety of the participants in the study and / or alters the benefit / risk balance. A report will be prepared independently and sent to the INS and the IRB involve, as son as posible, within a maximum period of seven (7) calendar days. DS 021-2017-SA (article 108, subsection h).

On June 30th, 2017 came into force the Supreme Decree N° 021-2017-SA that approved the Clinical Trials Regulation (CTR). This rule created the National Registry of Accredited Institutional Research Ethics Committees, and gave a period of one year from the approval of the Manual of Clinical Trial Procedures (that is, until November 17th, 2018) for all IREC to adapt their membership, responsibilities and procedures to the new regulations in order to be accredited (articles 58-66, CTR).

The General Office of Research and Technology Transfer of the National Institute of Health will accredit an IREC after reviewing its written procedures and conducting visits to verify compliance with the accreditation standards.

The following requirements need to be submitted to begin the accreditation process (article 63, CTR):

1. Application for Accreditation/Renewal of Accreditation (Form FOR-OGITT-025 printed)
2. Document issued by the authority of the Research Institution that creates the IREC.
3. Copy of the IREC Policy approved by the Research Institution which includes at least (article 65, CTR):
   • Membership Requirements
   • IREC Meetings Schedule
   • IREC Quorum Requirements
4. Copy of the IREC Procedures Manual approved by the Research Institution which includes at least (article 66, CTR):
   • Requirements for the Submission of Research Protocols
   • Procedures for the Continuing Review of Approved Research Protocols
   • Procedures for the IREC Meeting Minutes
   • Procedures for the IREC Records and Documentation
5. Declaration of Compliance with the Accreditation Standards (Form FOR-OGITT-026 printed).
6. Members’ CVs signed, with Certificates of Basic Training in Research Ethics attached.

NOTICE: All documents must be paginated according to the National Institute of Health’s guidelines for the submission of documents.

Electronic Form for the Accreditation of new IREC

Dear User:

If the IREC that is going to begin the Accreditation Process doesn’t have a registration code, please complete the following Registration form. Once completed, click on ‘Save’ in order to generate your temporary registration code. Then, print the form, sign and attach it to the other requirements to be sent to The General Office of Research and Technology Transfer of the National Institute of Health.

National Registry of Accredited IREC

NOTICE: The term “EXPIRED” is referred to the validity of the IREC registration under the repealed CTR. This implies that these IREC can’t approve new clinical trials or new research centers of previously approved protocols until the accreditation is granted. Other IREC responsibilities concerning approved research protocols are not affected by the accreditation process.