WEST VISAYAS STATE UNIVERSITY COLLEGE OF EDUCATION GRADUATE SCHOOL
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WVSU UBRERC SOP 03-02-2016 EFFECTIVE DATE: 01/12/2017
WEST VISAYAS STATE UNIVERSITY UNIFIED BIOMEDICAL RESEARCH ETHICS REVIEW COMMITTEE
3. POST APPROVAL PROCEDURES
3. Post Approval Procedures
3.1. Review of Serious Adverse Events 3.2. Review of Amendments 3.3. Review of Progress and Final Reports 3.4. Review of Protocol Violation/Deviation 3.5. Responding to Participant Requests/Queries 3.6. Site Visits 3.7. Review of Early Protocol Termination
Supersedes: October 15, 2014 SOP of the UBRERC
Authored by: WVSU UBRERC SOP Team (based on DOH & FERCAP 2012 Template) Fred P. Guillergan, M.D. Tomasito R. Sy, M.D. Edna A. Medez, M.D. Roberto P. Villanueva, M.D., LL.B. Victor A. Amantillo Jr., M.D. Ma. Pilar S. Malata, M.S., M.P.H.
Effective Date: January 12, 2017
Endorsed for approval by:
Fred P. Guillergan, M.D. Chair of the Committee
Approved by: Luis M. Sorolla Jr., Ph.D. WVSU President
Approval Date: October 21, 2016
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WVSU UBRERC SOP 03-02-2016 EFFECTIVE DATE: 01/12/2017
WEST VISAYAS STATE UNIVERSITY UNIFIED BIOMEDICAL RESEARCH ETHICS REVIEW COMMITTEE
3. POST APPROVAL PROCEDURES
This part describes the review procedures of the West Visayas State University UBRERC related to events reported to the UBRERC and Principal Investigator submissions required by UBRERC during the conduct of the study. The period covered begins after approval has been granted by the UBRERC until the completion of the study at the UBRERC approved site.
3.1 Review of Serious Adverse Events
3.1.1 Purpose To describe the UBRERC review procedures for Serious Adverse Events (SAE).
3.1.2 Scope This SOP applies to the review of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports submitted by investigators and sponsors to the West Visayas State University UBRERC to comply with ICH GCP. The UBRERC reviews such reports to determine appropriate action to protect the safety of participants in an approved study. ICH-GCP E6 defines a Serious Adverse Event (SAE) or a Serious Adverse Drug Reaction (ADR) as any untoward medical occurrence that at any dose:
A. Results in death; B. Is life threatening; C. Requires hospitalization or prolongation of existing hospitalization; D. Results in persistent or significant disability or incapacity, or; E. Results in a congenital anomaly or birth defect.
A Suspected Unexpected Serious Adverse Reaction (SUSAR) is a serious event the nature and severity of which is not consistent with the applicable product information. In the case of an unapproved investigational product, the event is not consistent with the Investigator’s Brochure (IB). In the case of a licensed product, the event is not consistent with the approved package insert or summary of product characteristics.
3.1.3 Responsibilities A. The primary responsibility of the West Visayas State University UBRERC is to conduct an
appropriate review of SAE and SUSAR reports to ensure oversight over the safety of participants enrolled in the study.
B. The UBRERC should also make sure that researchers are made aware of its policies and procedures concerning SAE reporting.
C. The West Visayas State University UBRERC sets up the necessary mechanisms to receive SAE and SUSAR reports from investigators and sponsors of researches that it has approved.
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WVSU UBRERC SOP 03-02-2016 EFFECTIVE DATE: 01/12/2017
WEST VISAYAS STATE UNIVERSITY UNIFIED BIOMEDICAL RESEARCH ETHICS REVIEW COMMITTEE
3. POST APPROVAL PROCEDURES
D. The primary responsibility of the West Visayas State University UBRERC is to receive and review SAE and SUSAR reports from its own site and to take the necessary action to ensure the safety of participants in the study.
E. In multicenter studies, the UBRERC also receives SAE and SUSAR reports from other sites within and outside the country. It is the responsibility of the West Visayas State University UBRERC to be updated about safety issues related to studies that it has approved.
F. The West Visayas State University UBRERC has the authority to suspend or terminate approval of research at its site when the safety of participants is no longer assured. When West Visayas State University UBRERC takes such action, it is required to provide the reasons for its action and to promptly report such decision to the investigator, the sponsor, the institution and relevant regulatory authorities.
3.1.4 Process Flow/Steps
Diagram13. Review Process for Serious Adverse Events
3.1.5 Detailed Instructions Note: The UBRERC (responsibilities after approval) informs Investigators that they are required to report SAEs and SUSARs to the UBRERC for all studies approved by the UBRERC. They should use Form 3.1 to report SAEs.
STEP
1
2
3
4
5
6
7
ACTIVITY
Report SAE and SUSAR
Receives SAE and SUSAR reports
Refers SAE Reports to appropriate ERC Member (SAE/SUSAR Reviewer)
Reviews SAE and SUSAR
Summarizes and reports to Full Board for appropriate action
Discuss SAE/SUSAR and make recommendation
Informs Investigator, Sponsor & other officials about ERC decision, whenever it is necessary
PERSON RESPONSIBLE
Investigators, Sponsors
Secretariat
Secretariat
SAE/SUSAR Reviewer
SAE/SUSAR Reviewer
Chair, Members & Secretariat
Secretariat
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WVSU UBRERC SOP 03-02-2016 EFFECTIVE DATE: 01/12/2017
WEST VISAYAS STATE UNIVERSITY UNIFIED BIOMEDICAL RESEARCH ETHICS REVIEW COMMITTEE
3. POST APPROVAL PROCEDURES
Step 1 Investigators/Sponsors report SAE and SUSAR to the UBRERC Secretariat. Step 2 The Secretariat shall be responsible for receiving the SAE and SUSAR Reports, as well as
documenting in the incoming logbook the receipt of SAE/SUSAR Report. Step 3 The report should be referred by the Secretariat to the SAE/SUSAR reviewer within 5
working days of receipt. The reviewer should classify the SAE/SUSAR Reports according to their origin or sites where they happened: On-site, Off-site within the Country, Off-site outside the Country. Classification of SAE/ SUSAR according to site – The UBRERC reviewers should adopt appropriate response depending on the site where the SAE/ SUSAR happened. A. For multicenter, international studies, note the trend of occurrence of SAE/ SUSAR in
study sites in foreign counties and other local sites. B. For multicenter, national studies, note the nature (related or expected) of the SAE/
SUSAR C. For SAEs that occur onsite, the West Visayas State University UBRERC should analyze
the investigator/sponsor assessment (related, unexpected) and may need to recommend some form of action to the Investigator to ensure the safety of participants.
Step 4 The SAE/SUSAR Reviewer reviews the report. Review of the report is based on: A. The Form 3.1 Serious Adverse Event Report Form will be used. B. Section 1 of the form should be filled out by the Principal Investigator. C. Section 2 should be filled out by the Secretariat (acknowledgement of receipt and by
the reviewer (reviewer’s evaluation/recommendation). D. The review procedures are as follows:
1. Assessment of the SAE is unlikely or unrelated to the study drug or article: The report is forwarded to the Chair for review and determination if the report should be reviewed at the convened meeting by Full Board.
2. Assessment of the SAE is definitely, possibly, or probably related to the study drug or article: The report is added to the agenda for review at a convened meeting by Full Board.
3. Assessment of the SAE is unexpected/ unanticipated and definitely, possibly, or probably related to the study drug or article: The report is added to the agenda for review at a convened meeting by Full Board.
E. SAEs and SUSARs are discussed and reviewed during regular UBRERC meetings for appropriate action.
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3. POST APPROVAL PROCEDURES
Step 5 The SAE/SUSAR Reviewer summarizes and presents for discussion the report in the UBRERC regular meeting. The Chair presides over the board discussion of the SAE’s and similar adverse experiences or advisories.
Step 6 The UBRERC Members discuss the SAE and SUSAR Report and make a recommendation. If
appropriate to the discussions, the Chair or another Board Member may call for a consensus on whether to: A. Request an amendment to the protocol or the consent form; B. Request further information; C. Suspend the approval of the study; D. Take note and no further action needed.
Step 7 The Secretariat informs the Investigator and or other concerned officials about ERC
decision, whenever it is necessary and keeps a record in the UBRERC files. A. If any of the above actions are taken (Step 6), the Secretariat notifies the Investigator
of the action taken. B. If the West Visayas State University UBRERC takes no action, a notation is made in the
minutes and the study is allowed to continue. C. The Secretariat prepares a formal letter to the Investigators or the clinical trial office
to notify them of the action they should take according to the West Visayas State University UBRERC decision.
D. The Chair signs and dates the letter. E. The Secretariat then sends the letter and records the delivery date.
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WVSU UBRERC SOP 03-02-2016 EFFECTIVE DATE: 01/12/2017
WEST VISAYAS STATE UNIVERSITY UNIFIED BIOMEDICAL RESEARCH ETHICS REVIEW COMMITTEE
3. POST APPROVAL PROCEDURES
3.2 Review of Amendments
3.2.1 Purpose To describe the UBRERC review procedures for amendments of the protocol and related documents.
3.2.2 Scope This SOP applies to previously approved study protocols and related documents that are being amended later and submitted for approval by the West Visayas State University UBRERC. Any amendment of the study related documents may not be implemented until reviewed and approved by the UBRERC.
3.2.3 Responsibilities It is the responsibility of the UBRERC Secretariat to manage protocol amendment package submitted by the Principal Investigator.
It is the responsibility of the original Primary Reviewers to review the amendments and recommend appropriate action.
It is the responsibility of the UBRERC Chair to determine whether the amendment is Expedited or Full Board Review. The UBRERC approves the final decision for amendments submitted by the PI to the UBRERC.
3.2.4 Process Flow/Steps
Diagram14. Steps in Reviewing Amendments
STEP
1
2
3
4
5
6
7
8
ACTIVITY
Submits Application for Amendment
Receives and manages Amendment Package
Refers Amendment Documents to original Primary Reviewers
Review amendments and make a recommendation
Reviews recommendations and determines if amendment should be referred to Full Board
Discuss at Full Board, if necessary
Informs PI about ERC decision
Keeps a copy of all amendment related documents in the protocol file
PERSON RESPONSIBLE
Principal Investigator
Secretariat
Secretariat
Primary Reviewers
Chair
Members
Secretariat
Secretariat
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3. POST APPROVAL PROCEDURES
3.2.5 Detailed Instructions Step 1 The UBRERC should properly inform Investigators to submit an amendment application
whenever there is any change regarding the composition of the study team, the study site and the protocol related documents for approvals previously granted by the UBRERC.
Step 2 The UBRERC Secretariat receives and checks the completeness of the amendment
package submitted by the Investigator. Use Form 2.1 and Form 3.2. Step 3 The UBRERC Secretariat refers the amendment package to the original Primary
Reviewers. Step 4 The original Primary Reviewers check the amended documents and compare them with
the previously UBRERC approved documents in the protocol files. They check if the amendments would alter the risk/ benefit ratio of the study to make appropriate recommendations using Form 3.2. Amendments that may potentially alter the risk/ benefit ratio of a study are referred to full board for discussion.
Step 5 The Chair reviews the recommendations and determines if amendment should be
referred to Full Board. Protocol amendment which increases risk to study participants may include, but is not limited to the following:
A. A change in study design; B. Additional treatments or the deletion of treatments; C. Any change in the inclusion/exclusion criteria; D. Change in method of drug intake or route of drug intake (e.g. oral changed to
intravenous); E. Significant change in the number of subjects (increase or decrease in sample size
that alters the fundamental characteristics of the study); F. Significant decrease or increase in dosage amount.
If only minor changes are involved in the amendment, the reviewers recommendation become the basis for the final decision of the UBRERC and a letter granting approval is prepared by the UBRERC Secretariat. If major changes are involved in the amendment (alters the risk/ benefit ratio of the study), the amendment is referred to Full Board after review by the Primary Reviewers. The members discuss the issues related to the amendments to arrive at a decision.
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3. POST APPROVAL PROCEDURES
Step 6 The UBRERC Members discuss the protocol amendment at Full Board. Step 7 The Secretariat prepares a communication letter to inform the Investigators about the
board decision. The Secretariat forwards the letter to the Investigators for proper action. Step 8 The Secretariat keeps a copy of all amendment related documents in the protocol files
and updates the UBRERC protocol data base.
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3. POST APPROVAL PROCEDURES
3.3 Review of Progress and Final Reports
3.3.1 Purpose To describe the UBRERC review procedures for Progress and Final Reports.
3.3.2 Scope This SOP provides instructions for the review of Progress Reports that are required by the West Visayas State University UBRERC to be submitted by the PI to monitor the safety of participants enrolled in a study. The Annual Progress Report becomes the basis for continuing review of protocols whose approval needs to be renewed every year. This SOP also aims to provide instructions for the review of Final Reports that are submitted by the PI after completion of subject enrollment and all follow up procedures. This SOP applies to conducting any continuing review of study protocols involving human subjects at intervals appropriate to the degree of risk but not less than once a year. Depending upon the degree of risk to the participants, the nature of the studies, and the vulnerability of the study participants and duration of the study, the UBRERC may choose to review or monitor the protocols more frequently. This SOP describes the follow up of Progress and Final Reports by the UBRERC Secretariat and the review of such reports submitted by the PI by designated members of the UBRERC in compliance with ICH-GCP requirements.
3.3.3 Responsibility It is the responsibility of the West Visayas State University UBRERC Secretariat to remind Investigators to submit the Progress and Final Reports before due date, to forward the reports to the Primary Reviewers for review comments, to communicate with the Investigators if there is need for further information or action and to submit to Full Board a list of Progress and Final Reports for approval. It is the responsibility of the Primary Reviewers to review the reports to check completeness of information and ensure that the data are in accordance with the protocols and other related documents approved by the UBRERC.
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3. POST APPROVAL PROCEDURES
3.3.4 Process Flow/Steps for Progress/Final Report Expedited Review
Diagram15. Steps in Reviewing Progress & Final Reports for Expedited Review
3.3.5 Detailed Instructions Submission and management of Progress/Final Reports for Expedited Review Step 1 The Secretariat checks the database and tracks due dates of Progress or Final Reports of
study protocols approved initially by Expedited Review by the West Visayas State University UBRERC.
Strep 2 The Secretariat prepares and sends reminder letter/notice addressed to the PI one month
before the due date of the report. Step 3 The Secretariat reviews the completeness of submitted report based on the items in
Progress Report (Form 3.3) or Final Report (Form 3.4). Step 4 The Member-Secretary or the Chair determines whether the Progress/Final Report is for
Expedited Review.
STEP
1
2
3
4
5
6
7
8
9
ACTIVITY
Checks the database and tracks due dates of Progress or Final Reports
Reminds PIs to submit Progress or Final Report one month before due date
Checks completeness of information in the report
Determines if the report is for Expedited Review and forwards to the reviewers for assessment/comments
Review the Progress or Final Report if it is in accordance with the approved protocol and related documents
Recommend approval or require more information or other action from the PI
Submit recommendation to Secretariat
Reports approval/ other recommendations to Full Board
Communicates ERC decision to PI
PERSON RESPONSIBLE
Secretariat
Secretariat
Secretariat
Chair/Member -Secretary
Reviewers
Reviewers
Reviewers
Secretariat
Secretariat
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3. POST APPROVAL PROCEDURES
The Member-Secretary or the Chair forwards the Progress/Final Report to the reviewers who reviewed the protocol initially.
Step 5 The reviewers conduct review of Progress/ Final Report if they are in accordance with the protocol and related documents approved by the UBRERC. The reviewers refer to the protocol file to check compliance with approval given by the UBRERC during initial review and upon submission of amendments.
Step 6 The reviewers recommend approval of the Progress/Final Report if there is no deviation or violation of UBRERC approvals. If there is any deviation or violation of approvals given by the UBRERC, the Primary Reviewers recommend that appropriate action be taken by the PI (e.g. amendment of the protocol or consent form, etc. for Progress Reports; explanation of deviation or violation for final reports, etc.)
Step 7 The reviewers submit decision/recommendation written in Progress Report Form (Form 3.3) and/or Final Report Form (Form 3.4)
Step 8 Approval or other recommendations by the Primary Reviewers of Progress/ Final Report
is submitted to the Secretariat and reported to the board meeting. Step 9 The Secretariat communicates the decision to the PIs.
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3. POST APPROVAL PROCEDURES
3.3.6 Process Flow/Steps for Progress/Final Report Full Board Review
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Diagram16. Steps in Reviewing Progress & Final Reports for Full Board Review
3.3.7 Detailed Instructions Submission and management of Progress/Final Reports for Full Board Review Step 1 The Secretariat checks the database and tracks due dates of Progress or Final Reports of
study protocols approved initially by Full Board by the West Visayas State University UBRERC.
Step 2 The Secretariat prepares and sends reminder (letter/notice) addressed to the PI one month before the due date of the report.
The Secretariat notifies the Investigator about the renewal of approval of the protocol and related documents to enable the PI to continue the conduct of the research.
STEP
1
2
3
4
5
6
7
8
9
10
11
12
ACTIVITY
Checks the database and tracks due dates of Progress or Final Reports of approved protocols
Reminds PIs to submit Progress or Final Report one month before due date
Submits Progress or Final Report on or before due date
Checks completeness of information in the report
Determines if the report is for Full Board Review and forwards to the Primary Reviewers for assessment/comments
Review the Progress or Final Report if it is in accordance with the approved protocol and related documents
Recommend approval or require more information or other action from the PI
Submit recommendation to Secretariat
Includes submitted recommendations in the agenda
Discuss the report and other recommendations in Full Board and make a decision
Communicates ERC decision to PI
Keeps a copy of the Progress/Final Report in the protocol file
PERSON RESPONSIBLE
Secretariat
Secretariat
Principal Investigator
Secretariat
Chair/Member-Secretary
Primary Reviewers
Primary Reviewers
Primary Reviewers
Secretariat
ERC members
Secretariat
Secretariat
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3. POST APPROVAL PROCEDURES
(Approval of the Annual Progress Report is necessary to renew the initial approval of the protocol and allow the Investigator to continue the conduct of research).
Step 3 The Principal Investigator submits the Annual Progress Report or Final Report using the Progress Report Form (Form 3.3) or Final Report Form (Form 3.4).
Step 4 The Secretariat reviews the completeness of submitted reports. Step 5 The Member-Secretary or the Chair determines whether the Progress/Final Report is for
Full Board Review. Review of Progress/Final Reports of protocols reviewed initially in Full Board should be done in Full Board. The Member-Secretary or the Chair forwards the Progress/Final Report to the Primary Reviewers who initially reviewed the protocol for assessment.
Step 6 The Primary Reviewers refer to the protocol file to check compliance with approval given by the UBRERC during initial review and upon submission of amendments. The Primary Reviewers check if the report is in accordance with the protocol and related documents approved by the UBRERC. The Primary Reviewers review the Progress/Final Report.
Step 7 The Primary Reviewers recommend approval or require more information or other action plan for the PI.
Step 8 The Primary Reviewers submit to the Secretariat the recommendation for approval of
the Progress/Final Report if there is no deviation or violation of UBRERC approvals. If there is any deviation or violation of approvals given by the UBRERC, the Primary Reviewers recommend that appropriate action be taken by the PI (e.g. amendment of the protocol or consent form, etc. for Progress Reports; explanation of deviation or violation for Final Reports, etc.).
Step 9 The Secretariat includes related issues or recommendations to Progress/Final Reports in the agenda.
Step 10 UBRERC Members discuss the reports and recommendations in Full Board Meeting and
make a decision. Step 11 The Secretariat takes note of the decision. The decision is communicated to the PI.
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3. POST APPROVAL PROCEDURES
Step 12 The UBRERC Secretariat keeps a copy in the protocol files of the Progress/Final Report
signed and dated by the Primary Reviewers and the Chair or Member-Secretary and updates the UBRERC protocol data base.
Note: Approval of the Final Report enables the UBRERC Secretariat to close the protocol files. The UBRERC Secretariat marks the folder of the completed protocol and archives the entire study protocol.
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3. POST APPROVAL PROCEDURES
3.4 Review of Protocol Violation/Protocol Deviation
3.4.1 Purpose To describe the UBRERC review procedures for Protocol Violation/Deviation.
3.4.2 Scope This SOP provides instructions for taking action and maintaining records of various types of Protocol Deviation or Violations:
A. It includes Investigators who fail to comply with the procedures in the approved protocol or to comply with national/ international guidelines for the conduct of human research, including those who fail to respond to the West Visayas State University UBRERC’s requests.
B. It also covers action taken by the UBRERC related to Protocol Violation/Deviation Reports submitted by the PI related to any event at the site that is not in compliance with the protocol documents previously approved by the UBRERC.
3.4.3 Responsibility It is the responsibility of the UBRERC Secretariat to receive Protocol Violation/Deviation Reports submitted to the UBRERC. It is the responsibility or the Board Members or designated members to take action related to Protocol Violation/Deviation.
3.4.4 Process Flow/Steps
Diagram 17. Review Process for Protocol Violation/Deviation
STEP
1
2
3
4
ACTIVITY
Receives Protocol Violation/Deviation Reports
Discuss at Full Board and make a decision
Notifies the Principal Investigator
Keeps records
PERSON RESPONSIBLE
Secretariat
Members
Secretariat
Secretariat
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3. POST APPROVAL PROCEDURES
3.4.5 Detailed Instructions
Step 1 The Secretariat receives the Protocol Violation/Deviation Reports from Investigators and other parties related to any event in the site that is not in compliance with the previously UBRERC approved protocol and related documents. The Secretariat gets full information about the event and puts the report in the next full board meeting agenda.
Step 2 The UBRERC Members discuss the protocol amendments at Full Board and make a decision. A. Whenever Protocol Deviation /Non-compliance /Violation has been observed:
1. Ensure that the issues as well as the details of non-compliance involving research investigators are included in the agenda of the West Visayas State University UBRERC meeting.
2. Maintain a file that identifies Investigators who are found to be non-compliant with national/international regulations or who fail to follow protocol approval stipulations or fail to respond to the West Visayas State University UBRERC’s request for information/action.
3. The West Visayas State University UBRERC may elect to suspend or terminate approval of current studies or refuse subsequent applications from the investigators cited. Such decisions are recorded in the minutes.
B. Basis of committee/board action/decision; Prior approval may be withdrawn for the following reasons: 1. SAE directly or indirectly attributed to the research; 2. Breach of previously approved conduct of the research; 3. Major changes, deviations or amendments to the approved protocol without
another approval by the UBRERC; 4. Revisions in the Informed Consent Form.
Step 3 Notification of the West Visayas State University UBRERC’s decision. The Secretariat: A. Records the West Visayas State University UBRERC decision. B. Drafts and types a notification letter. C. Gets the Chair to sign and date the letter. D. Makes four copies of the notification letter. E. Sends the original copy of the notification to the Investigator. F. Sends a copy of the notification to the relevant national authorities and institutes. G. Sends the third copy to the sponsor or the sponsor’s representative of the study.
Step 4 The Secretariat keeps records. A. Keeps the last copy of the notification letter in the “non-compliance” file. B. Stores the file in the shelf with an appropriate label. C. Follows up the action after a reasonable time. D. Updates protocol deviation data base.
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3.5 Responding to Participant Requests/Queries
3.5.1 Purpose To describe the ERC procedures related to participant requests and queries.
3.5.2 Scope This SOP applies to all queries and requests related to the rights and well-being of the research participants in studies approved by the West Visayas State University UBRERC.
3.5.3 Responsibility A designated member of the Secretariat is responsible for receiving participant queries and requests related to their participation, refers relevant issues to the ERC Chair or members for the ERC to take appropriate action. The Secretariat keeps records of all action taken by the ERC.
3.5.4 Process Flow/Steps
Diagram 18. Steps in Responding to Requests/Queries
STEP
1
2
3
4
5
ACTIVITY
Receives the request or query
Assesses nature of the request and refer to appropriate person
Takes action and refers to Full Board if necessary
Communicates decision to person who made the query
Files the documents
PERSON RESPONSIBLE
Secretariat
Secretariat/Chair
Chair/Members
Secretariat
Secretariat
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3. POST APPROVAL PROCEDURES
3.5.5 Detailed Instructions
Step 1 The Secretariat receives the request or query. A. The West Visayas State University UBRERC Secretariat receives the inquiry or requests
from research participants/patients or the community through various forms of communication (email, telephone call, letter, etc.).
B. Replies to the request or query, if it is within the authority of the Secretariat or refers to the Chair or UBRERC Member for appropriate action.
C. Records the request and information in the Request/Query Record Form (Form 3.6) and keeps a copy in the files.
Step 2 The Chair or Secretariat assesses nature of the request and refers to appropriate person. Step 3 The Chair or Member takes appropriate action;
A. Investigate the fact. B. Records information and any action or follow-up taken in the Form 3.6 C. Signs and dates the form and forwards to the Secretariat for filing. D. Reports to the UBRERC about the action taken and the outcomes.
Step 4 The Secretariat communicates the decision to the person who made the query. Step 5 The Secretariat files the request document.
A. Keeps the record form in the “response” file. B. Keeps a copy in the study file. C. Stores the file in the appropriately labeled shelf.
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3. POST APPROVAL PROCEDURES
3.6 Site Visits
3.6.1 Purpose To describe the UBRERC procedures related to the conduct of site visits.
3.6.2 Scope This SOP applies to any visit made in any study site, on behalf of the West Visayas State University UBRERC, to check compliance with GCP and UBRERC approved protocol and related documents. 3.6.3 Responsibility It is the responsibility of the West Visayas State University UBRERC to perform or designate some members or qualified representatives to perform on its behalf on-site visit of the research projects it has approved. The West Visayas State University UBRERC Members or Secretariat in consultation with the Chair may initiate an on-site evaluation of a study site for cause or for a routine audit.
3.6.4 Process Flow/Steps
Diagram 19. Process in Conducting Site Visits
STEP
1
2
3
4
5
6
7
8
ACTIVITY
Select study sites and inform the PI about the planned visit
Check approval given by the UBRERC from the protocol files and collect relevant information about the study site
Check the onsite documents and compare with documents in the protocol files; interview PI and/or research staff
Write a report and make a recommendation
Present the findings to the Full Board which adopts an appropriate action
Communicates board decision to the PI
Implements board recommendation and reports action to the board
Files copies of documents
PERSON RESPONSIBLE
Members and Secretariat
Members and or UBRERC Representative
Members and//or UBRERC Representative
Members and/or UBRERC Representative
Members and/or UBRERC Representative
Secretariat
Principal Investigator
Secretariat
A
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3.6.5 Detailed Instructions
Step 1 The UBRERC Members and Secretariat select the study sites to visit. A. The Secretariat reviews periodically the database files of the submitted/approved
study protocols. B. The Members and Secretariat select study sites needed to be monitored based on the
following criteria: 1. New study sites or new PIs; 2. Reports of remarkable serious adverse events; 3. Big number of studies carried out at the study site; 4. Frequent protocol submission for West Visayas State University UBRERC review; 5. Non-compliance or suspicious conduct; 6. Frequent failures to submit Final Reports; 7. Frequent protocol violations.
C. The Secretariat contacts the site to notify that they will be visited and coordinates a time for the site evaluation visit.
D. The Secretariat makes the appropriate travel arrangements.
Step 2 The UBRERC Representative and/or Member review the West Visayas State University UBRERC files for the study and site. Make appropriate notes, or copies some parts of the files for comparison with the site files.
Step 3 The UBRERC Representative and/or Member checks the onsite documents and compares
it with that of the protocol files and interviews the PI and or the research staff. A. Use the Site Visit Report Form (Form 3.7). B. West Visayas State University UBRERC representatives will:
1. Review the informed consent document to make sure that the site is using the most recent version;
2. Review randomly the subject files to ensure that subjects are signing the correct informed consent;
3. Check if the files are orderly and confidentiality is maintained; 4. Debrief the PI about site visit findings and comments; 5. Get immediate feedback.
Step 4 The UBRERC Representative will: 1. Write a report/comment (use Form 3.7) within 1 week describing the findings
during the visit; 2. Forward a copy of the site visit to the Secretariat for inclusion in the next board
meeting; 3. Send a copy of the report to the site for their files, and 4. Place the report in the correct site files.
A
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Step 5 The UBRERC Representative and/or Member presents the site findings to the Full Board. The Board makes a decision about appropriate action.
Step 6 The Secretariat communicates the board decision to the PI for appropriate action. Step 7 PI follows board recommendation and reports to the UBRERC. Step 8 The Secretariat reports PI’s action to the board. Secretariat keeps a copy of the files.
A
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3.7 Review of Early Protocol Termination
3.7.1 Purpose To describe the UBRERC procedures related to early termination of protocol implementation.
3.7.2 Scope This procedure describes how the UBRERC proceeds and manages the premature or early termination of a protocol when subject enrollments are discontinued before the scheduled end of the study. Protocols are usually terminated at the recommendation of the Data Safety Monitoring Board (DSMB), the Scientific Director, Sponsor, Principal Investigator, by the ERC itself or other authorized bodies.
3.7.3 Responsibility It is the responsibility of the UBRERC to act on any early protocol termination application. It is also the responsibility of the UBRERC to withdraw approval for any previously approved protocol when the safety or benefit of the study participants is doubtful or at risk. All applications are reviewed at Full Board for appropriate action. The Secretariat is responsible for the receipt and management of the termination documentation. The Primary Reviewers review the reasons for early termination and make a recommendation to Full Board.
3.7.4 Process Flow/Steps
Diagram 20. Early Protocol Termination Process
STEP
1
2
3
4
5
6
ACTIVITY
Receive the application or recommendation for early termination
Checks approval given by the UBRERC from the protocol files and collects relevant information
Reviews the termination package or termination issues and makes recommendations
Discuss at Full Board for appropriate decision
Communicates board decision to the PI
Files copies of documents
PERSON RESPONSIBLE
Members and Secretariat
Primary Reviewers/ Designated Member
Primary Reviewers/Designated Member
Members
Secretariat
Secretariat
A
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3.7.5 Detailed Instructions Step 1 The Secretariat and then the UBRERC Members receive application or recommendation
for early study termination. A. Receive recommendation and comments from the Sponsor, DSMB, UBRERC
Members, Scientific Director, or other authorized bodies for study protocol termination.
B. Inform the Principal Investigator to prepare and submit a protocol termination package.
C. Receive the study protocol termination package prepared and submitted by the Principal Investigator.
D. Check the completeness of the contents of the package to include the Study Termination (Form 3.8).
E. The request for termination memorandum should contain a brief written summary of the protocol, its results, and accrual data.
Step 2 The Primary Reviewer or UBRERC designated member checks approval given by the UBRERC from the protocol files and collects relevant information.
Step 3 The Primary Reviewer or UBRERC designated member reviews the termination package or
termination issues and makes recommendations. The designated reviewer reviews the safety data. It is important for the termination package to contain a plan to follow up the participants who are still active in the study.
Step 4 The Members discuss at Full Board for appropriate decision. Step 5 The Secretariat communicates the UBRERC decision. Step 6 The Secretariat updates the protocol file and data base.
A
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FORM 3.1 SERIOUS ADVERSE EVENT REPORT FORM Whenever there is any Serious Adverse Event (SAE) in any research approved by the West Visayas State University UBRERC, it has to be reported by the Principal Investigator (PI) to the UBRERC. Section 1 of this form should be filled out by the PI. SECTION 1
UBRERC Protocol Number
Sponsor Protocol Number Date of Submission
Principal Investigator
Protocol Title
Name of the study Medicine/Device Onset Date
Initial
Follow Up
Sponsor Date of First Use
Title of the Report Date of the Report
Subject’s Initials / Number Code Male
Age Female
Subject’s History Laboratory Findings
SAE Treatment Outcome:
Resolved On-going
A
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Seriousness: Relation to
Death Life Threatening Drug Device Study
Hospitalization: Not related
Initial Prolonged Possibly
Disability/Incapacity Probably
Congenital Anomaly Definitely related
Others Unknown
Note: PI should attach standard SAE report form to this ERC form.
SECTION 2 (to be filled out by the designated UBRERC representative)
Document receipt by the UBRERC
Name (UBRERC Secretariat) Signature Date
Reviewer/s Recommendations
Reviewer’s Name Signature Date
Changes to the protocol recommended No Yes
Comments:
Changes to the informed consent form recommended? No Yes
Comments:
A
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ERC Final Action:
Request an amendment to the protocol or the consent form.
Request further information.
Suspend or terminate the study
Take note and no further action is needed.
Others:
Date of Full Board Meeting
___________________________________________ __________________________ Member-Secretary, WVSU UBRERC Date
A
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FORM 3.2 PROTOCOL AMENDMENT REVIEW
UBRERC Protocol Number Sponsor Protocol Number Date of Submission
Date of Approval
Protocol Title
Principal Investigator Sponsor Contact Number
List of Amendments Reasons
1.
2.
3.
Comments of Primary Reviewers
Reviewer’s Name & Signature _______________________________
UBRERC Decision
________________________________ ________________________
Chair, WVSU-UBRERC Date
A
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FORM 3.3 PROGRESS REPORT
UBRERC Protocol Number Date of Approval
Protocol Title
Principal Investigator Sponsor
ACTION REQUESTED:
Renew - New Participant Accrual to Continue
Renew - Enrolled Participant Follow Up Only
Terminate - Protocol Discontinued
Any amendment since the last review? (Describe briefly.) No Yes
Any change in participant population, recruitment or selection criteria since the last review? (Explain the changes.)
No Yes
Any change in the Informed Consent process or documentation since the last review? (Please explain.)
No Yes
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Is there any new information in recent literature or similar research that may change the risk/ benefit ratio for participants in this study? (Discuss and attach a narrative.)
1.
No Yes
Any unexpected complication or side effect noted since the last review? (Discuss and attach a narrative)
No Yes
Did any participant withdraw from this study since the last approval? (Reasons for withdrawal)
5.
No Yes
Any new Investigator that has been added to or removed from the research team since the last review? (Please identify them and submit the CVs of new Investigators.)
6.
No Yes
Summary of Protocol Participants:
Accrual ceiling set by UBRERC
New participants accrued since last review
Total participants accrued since protocol began
A
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ACCRUAL EXCLUSIONS
None
Male
Female
Others (Specify)
Are there any new collaborating sites that have been added or deleted since the last review? Please identify the sites and note the addition or deletion.
No Yes
Impaired Participants
None Physically Cognitively Both
To be filled out by UBRERC
Date Received Received By
Printed Name
Signature
Primary Reviewer Signature Date
Recommendations
Approve
Request an amendment to the protocol or the consent form
Request further information
Suspend or terminate the study
Others:
A
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Expedited
Type of Review
Full Board
Changes to the Protocol recommended Comments:
No Yes
Changes to the Informed Consent Form recommended? Comments:
No Yes
UBRERC Final Decision
Certified by: Name of Member-Secretary Signature Date
A
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FORM 3.4 FINAL REPORT
UBRERC Protocol Number Date of Approval
Protocol Title
Principal Investigator
Contact Number E-mail Address
Sponsor
Address
Contact Number E-mail Address
Study Site(s)
Total Number of Study Participants
Number of Study Arms
Number of Participants who Received the Test Articles
Study Materials
Treatment Form
Study Dose(s)
Duration of the Study
Objectives
Results: (Use extra blank paper, if more space is required.)
Signature of Principal Investigator
A
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FORM 3.5 DEVIATION / NON-COMPLIANCE / VIOLATION REPORT
UBRERC Protocol Number Sponsor Protocol Number Date of Submission
Protocol Title
Principal Investigator Contact Number
Sponsor Contact Number
Reported By Contact Number
PI Deviation from protocol Participant Non-Compliance
Major Minor
Description
UBRERC Decision
Actions Taken
Reported By Noted By: (Secretariat)
Date Date
A
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FORM 3.6 REQUEST/ QUERY RECORD
Date Received Received By
Request from : Telephone call Number
Fax Number
Mailed letter / Date
E-mail / Date
Walk-in/Date/Time
Others (specify)
Participant’s Name
Contact Address Contact Number
Title of the Participating Study
Starting Date of Participation
Requests
Action Taken
Outcome
A
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FORM 3.7 SITE VISIT REPORT
UBRERC Protocol Number
Date of the Visit
Protocol Title
Principal Investigator/s Contact Number
Institution/Department Address
Sponsor Address
Total Number of Expected Subjects
Total Subjects Enrolled
Are site facilities appropriate? Comment:
Yes No
Are Informed Consents recent? Comment:
Yes No
Any adverse events found? Comment:
Yes No
Any protocol non
compliance/violation? Comment:
Yes No
A
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Are all Case Record Forms up to
date? Comment:
Yes No
Are storage of data and investigating
products locked? Comment:
Yes No
How well are participants protected? Comment:
Good Fair Not good
Any outstanding tasks or results of
visit? Give Details:
Yes No
Duration of Visit (Hours) Start Time End Time
Name of UBRERC Member/Representatives and Companion
Completed By Date
A
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FORM 3.8 STUDY TERMINATION
UBRERC Protocol Number Sponsor Protocol Number
Protocol Title
Principal Investigator
Contact Number E-Mail Address
Institution/Department
Sponsor
UBRERC Date of Approval Date Of Last Report
Starting Date Termination Date
Number of Participants Number Enrolled
Summary of Results
Accrual Data
Principal Investigator’s Signature
Date
A
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History of WVSU UBRERC SOP Chapter 3
Version No. Date Authors Main Changes
01 2014 October 15 Henrietta C. Española, M.D.
First Draft
02 2016 October 21 Tomasito R. Sy, M.D. Fred P. Guillergan, M.D.
In 3.1.2 the word SUSAR was spelled out as Suspected Unexpected Serious Adverse drug Reaction.
Detailed Instructions in 3.1.5 were revised in order to harmonize it with the Process Flow tabulated in 3.1.4.; Emphasis was on classifying the SAE/SUSAR as to On-site, Off-site within the Country, Off-site outside the Country.
Detailed Instructions in 3.2.5 were revised in order to harmonize it with the Process Flow tabulated in 3.2.4.
The Process Flow 3.3.4 and the corresponding Detailed Instructions, 3.3.5 were revised to be the process and steps for Reviewing Progress and Final Reports for Expedited Review. Section 3.3.6 and 3.3. 7 were added to depict the Process Flow and Detailed Instructions for Reviewing Progress Reports and Final reports for Full Board Review.
Detailed Instructions in 3.4.5 were revised in order to harmonize it with the Process Flow tabulated in 3.4.4.
Detailed Instructions in 3.5.5 were revised in order to harmonize it with the Process Flow tabulated in 3.5.4;
Detailed Instructions in 3.6.5 and 3.7.5 were revised in order to harmonize it with the Process Flow tabulated in 3.6.4 and 3.7.4 respectively