Interaction with Institutional Ethics Committee
Purpose
To describe the procedures related to communication with the Institutional Ethics Committee (IEC) during the entire study duration right from study initiation to completion, and to describe what documents should be retained to reflect interaction with the IEC.
Scope
This SOP will apply to all studies being conducted at the Site.
Procedure
Interactions with the Institutional Ethics Committee (IEC) continue throughout the duration of a research study Establishing effective ongoing IEC communication and reporting procedures is essential to the successful arrangement of research studies. An effective working relationship with the IEC strengthens the team's approach to the protection of participant safety in addition to enhancing compliance with applicable SOPs, guidelines, and regulations governing research studies.
Interaction with IEC is required during the entire course of the research study, the phases could be:
Initial Submission of the project to IEC
a. Detailed description of project submission
• The Pl/ Co-1/CTC should submit all study-related documents to the IEC, no fewer than fourteen ( 14) days before the scheduled meeting.
• The PI/Co- 1/C TC should complete the IEC submission form (Refer to IEC SOP) and the PI must sign and date the form wherever required.
PI/Co -1/CT C must check the submissions as per the IEC checklist (Refer to IEC SOP) to
Ensure that all mandatory forms and documents are enclosed.
• There will submit the signed forms and documents to the I EC. These include but are not limited to:
o Covering letter with a brief description regarding the List of documents enclosed for I EC approval, including the no. of copies submitted, document enclosed relevant version number, and date of all the documents.
o Project submission Form as mentioned above
o Study protocol
0 Other related documents necessary for initial review as mentioned in the IEC
o Curriculum Vitae and updated GCP certificate of the investigator and study team.
o IEC fees/Cheque in the favor of "…….'', in case of sponsored studies.
o Number of copies required for l EC submission will be as per IEC SOP Note: One additional copy for Pl Acknowledgement
The PI/CTC should keep a copy of the acknowledged (IEC stamp with sign and date) submission letter
or the above-mentioned documents in the Site Master File and send a scan or copy to the sponsor (via mail or courier as required by the sponsor).
Pl/CTC must document the unique " Project no." given by the IEC after project submission for future
communication and collect updated IEC membership roster and IEC registration number which should place in the Site Master File (SMF).
b. CC Response
The Pl and CTC should ensure that the letter of response from the IEC includes the following
information:
o Clinical study identification, protocol number, and title;
o Name and version date of all documents reviewed by the IEC.
o Date or review by the IEC
o Approval for the number of participants to be recruited in the study.
o Decision /opinion/approval or the clinical study including required modifications, if any; (Note: Reply to the IEC in case of any suggested modifications)
o l f conditional approval is given, it is not valid for more than 6 months (Refer to IEC SOP)
o Procedures for appealing the decision/opinion of the committee;
o Any other information, if applicable, as described in the IEC SOP
o Date of renewal of approval;
o Signature of the IEC member secretary and date of the response.
o Following Schedule Y and GCP (ICH 3.2.1 et 3.2.2) a list of the members of the Ethics Committee and their qualifications s. as well as the procedures of the said committee should be available.
o The PI/CTC should keep an original copy) or the SITs approval letter in the SMF and provide one copy to the sponsor /CRO (via email/fax).
o Immediately after receiving IEC approval, register the study on CTRI and if applicable on ClinicalTrials.gov
o Notify IEC after receiving the registration number.
Study Progress
Pl can start the project at the site after receiving an approval letter from IEC and as the study progress at the site Pl must communicate with IEC for all required notification and reporting such as:
Protocol Amendments
a. Major Amendments
Notify the IEC of any changes to the protocol and/or informed consent and/or of new information on the investigational product no fewer than fourteen (14) days before the next scheduled meeting.
All amendments should bear the amendment number and version number with the date(s).
CTC must make sure that all changes or modifications in the amended version are underlined or highlighted along with detailed summary of changes.
The amendment /documents along with the cover letter should be accompanied by Amendment Reporting Form (Refer to IEC SOP)
The number of copies required for IEC submission will be as per IEC SOP
Note: One additional copy for Pl Acknowledgement
The PI/Co-PI/CTC should obtain a copy of the acknowledged (IEC stamp with sign and elate) amendment submission letter of the above-mentioned documents, tile the same in the relevant section of SM F and send Scan or a copy to sponsor/ CRO(via email/fax).
The amendments in the protocol and/or informed consent and of new information on the IP will be valid only after IEC approval. and should immediately implement the documents at the site after approval. Document the approval letter in the relevant section of the SMF and send a copy to the sponsor /CRO (via call/fax)
b. Minor amendments and notifications
Minor amendments are those that do not increase the risk or decrease the potential benefit to subjects and may be approved by the IEC (Refer to IEC SOP).
This may include but may not restrict to:
o Renewed insurance policy
o DCGI and DGFT approvals
o Administrative notes
o Documents of administrative nature
Deviations/Violations and Waivers
• Submit protocol deviations/ violations and waivers to the IEC for review and approval according to IEC and regulatory requirements
• Deviation/ non-compliance/ violation/waiver happens at the site, when investigators/trial sites, fail to
o follow the proccdu1·es written in the approved protocol
o comply with national/ international guidelines for the conduct of human research
o fail to respond to the IEC requests
• PI/ Co-PI/CTC must submit the deviations/violations/ waiver reports as per the ….SOP.
• Protocol deviation/ non-compliance/ violation/waiver can be detected during monitoring visits for the investigator-initiated study by IEC and for sponsored studies by the monitor/ CRA also. Sometimes it can be detected by Pl /study team member.
• The IEC members and/or monitor/ CRA performing monitoring of the project at the study site can detect protocol deviation/non-compliance / violation. if the project is -
o not conducted as per protocol / national/international regulations
o when scrutinizing annual/ periodic reports / SAE reports
o fail to respond to requests from IEC within the reasonable time limit
o fail to adhere to protocol required procedures
• Protocol Waiver is analogous to a Protocol Deviation, except that prior IEC approval must be obtained before implementing the necessary departures from the protocol. Therefore, Protocol Waivers arc anticipatory while Protocol Deviations are not. E.g. Protocol Waiver means a prospective decision by a sponsor or investigator to permit accrual of a subject who does not satisfy the approved inclusion /exclusion criteria for enrollment.
• IEC action could include one or more of the following:
o IEC will inform the Pl that IEC has noted the violation/noncompliance/deviation and inform the Pl to ensure that deviations/noncompliance/violations do not occur in
future and follow IEC recommendations. ·r
o IEC will enlist measures that the Pl would undertake to ensure that deviations
/noncompliance/violations do not occur in the future.
o call for additional information
o Suspend the study till additional information is made available and is scrutinized
o Suspend the study till recommendations made by the IEC are implemented by the Pl and found to be satisfactory by the IEC
o Suspend the study for a fixed duration of time
o Inform the Director SITE
o Revoke approval of the current study
o Inform DCGI / Other relevant regulatory authorities
o Keep other research proposals from the Pl/ Co-Pl under abeyance
o Review and/or inspect other studies undertaken by Pl /Co-PI
• File the IEC acknowledged deviations/violations and waiver forms submitted to irrelevant files and send one copy to the sponsor /CRO.
Safety Information
• Safety information can be any information recently reported or obtained from the sponsor/CRO, particularly regarding risks associated with the research
• Safety information is categorized as Serious Adverse events (SAEs) and unexpected event reports of both onsite and offsite.
• The Principal Investigator must review safety information received from the sponsor.
• It is recommended that the Pl review of safety information must be documented.
• The Investigator must submit Serious Adverse events (SAEs) and unexpected events reports both onsite and offsite, including follow-up reports for active study participants.
• Report all safety information 10 the IEC according to the IEC and regulatory requirements (eg. investigational New Drug [IND] submissions, Council for International Organizations of Medical Sciences [CIOMS] reports, Suspected Unexpected Serious Adverse Reactions (SUSAR), Periodic Safety Update Report (PSUR), Data Safety Monitoring Board [DSMB] report s).
o File safety reports and any associated IEC correspondence, if any, in the SMF.
• Copies of the associated IEC correspondence should be provided to the sponsor according to sponsor requirements.
• Report any other information to the IEC that may adversely affect the safety of the participants or the conduct of the research study.
a. Off-Site Safety Reports
• Off Site SAEs are adverse event reports that are serious, expected, unexpected, related, and unrelated (definitely, probably, and possibly) to the drug and need prompt reporting to the IEC/DSM SC/Sponsor.
• The SAEs that are expected (if listed in the informed consent and 1B) or unexpected but unrelated to the drug (classified as per the Offsite SAE Classification form - as per IEC SOP) have to be logged by the Pl and to be submitted timely. The following log will be maintained continuously until the end of the study.
• IEC/DSM SC will accept the log of the SAEs every 3 months and/or at the time of continuing review/ annual status report.
• Those off-site SAEs which qualify for prompt reporting, (classified as per the Off-site SAE Classification form - as per IEC SOP) will be reported to IEC /DSMSC
• Sponsor/CRO will send two sets of the offsite SAE, CTC will submit one to the SEC/DSMSC (as per the IEC SOP) and file acknowledged (Stamped, signed, and dated by the IEC /DSMSC) copy in the SMF and send a copy to the sponsor/CRO.
• Pl's must review the SAEs listings in detail and report if a trend is observed and communicate the same to IEC/ DSMSC.
• Pl /Co I may receive email or letter as applicable, if any queries are raised by the SEC/DSMSC Secretary. Pl/Co-PI must reply to the query immediately.
b. On-site SAE reporting:
Kindly Refer to SOP for Safety Reporting
Annual Report/ Continuing Review Report
• The purpose of the Annual report/ continuing review report is to monitor the progress of the study which was previously approved: not only for the changes but to ensure continued protection of the rights and welfare of research subjects.
• Pl/Co-PI/ CTC must submit continuing review report/ annual report to the IEC annually, subsequent to the date of IEC approval to renew approval before two months of expiry.
" All information must be provided to IEC/DSM SC, as requested in the continuing review application form (Refer to IEC SOP)
• The investigator/CTC should submit the continuing review application well in advance i.e. 12 months after IEC final approval.
• CTC should submit three hard copies of the report (1+2) and a soft copy.
o ere should obtain a copy of the annual/continuing review report acknowledged by IEC, file the same in SMF and send a copy to the sponsor (via email/fax).
• The IEC Secretary will notify Principal Investigator in· case the committee recommended modifications, and the PI will be requested to resubmit the relevant documents within 1 month for approval till then the project is suspended.
• Principal Investigator will be communicated the decision within 14 working days after the minutes are finalized.
• The Pl will receive a letter from IEC/ DSMSC if the continuing review report/annual report is approved/accepted.
• The letter should be filed in the SMF and a copy should be provided to the sponsor.
Note: If there is a delay in approval of the continuing review report subsequently from the date of IEC approval, the PI cannot recruit any patient during that phase, till IEC /DSMSC, approves the continuing review report.
Study Termination
a. Premature Termination / Suspension /D is a continuation of the study
c Research studies are usually terminated as per the recommendation of the IEC/Pl, Sponsor or other authorized bodies wherein subject enrollment and subject follow-up are discontinued before the scheduled completion of the study.
• The IEC/Sponsor/Pl/ other authorized bodies can prematurely terminate the study for the following reason but not limited to:
o Protocol non-compliance/violation clue to any reason
o Slow recruitment
o Frequency of SAEs occurring at the trial site may require the study to be prematurely terminated for the safety of the patients.
o Sponsor finds treatment not effective
o, Lack of funds. lack of adequate market potential, competing drugs have received marketing approval ahead of the test compound. etc.
o Overall trial enrollment was met. so all sites are being closed, even if some sites
have not completed their enrollments.
• Based on the above-mentioned reasons IEC secretary can send a notification letter for
termination/suspension/discontinuation or query letter to request additional information to the Pl.
• In case the Sponsor is terminating the study, Pl will receive a letter from Sponsor /CRO for the termination/suspension/discontinuation with the explanation for the same.
• Pl and CT C will prepare the protocol termination package along with the covering letter Premature Termination Report (Refer IEC SOP) signed and dated by Pl and another material (e.g. letter received from the Sponsor/PI/IEC)
• CTC must obtain acknowledgment of the IEC member secretary on the cover letter and file it in the SMF.
• PI/CTC must reply immediately to file a case of any query generated or any further information requested from the I EC.
• Pl will receive an acceptance letter from the IEC, CTC will keep the original letter of the Premature Termination/suspension/discontinuation report in the study file and send the file to archive (Refer SOP; Archival of Essential Documents). In the form the same to Sponsor/CRO.
Study completion
• On the Study completion the Pl/CTC will notify the IEC of the study completion using the study completion form (Refer to IEC SOP)
• Additionally Pl and CTC must submit a letter provided by the sponsor/CRO to give adequate and sufficient information.
• CTC must submit one hard copy + soft copy of Study Completion Reports
Applicable Staff
This SOP applies to all the personnel of the clinical research team and others who may be responsible for the interaction with the IEC.
These include the following:
o Investigator
o Research Team (listed in the delegation log)
o CTC
o IEC staff members
END OF THE DOCUMENT
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