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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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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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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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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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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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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.


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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3.2.5 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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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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3.3 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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3.3.4 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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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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3.3.6 Process Flow/Steps for Progress/Final Report Full Board Review

D

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


Secretariat

Chair/Member-Secretary

Primary Reviewers

Primary Reviewers

Primary Reviewers

Secretariat

ERC members

Secretariat

Secretariat

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(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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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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3.4 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.


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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3.4.5 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.


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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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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3.6 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.


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


Secretariat

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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.

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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.

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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.


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

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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.

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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


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

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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:

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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

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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

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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

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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:

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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

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FORM 3.4 FINAL REPORT

UBRERC Protocol Number Date of Approval

Protocol Title


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

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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

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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

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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

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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

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FORM 3.8 STUDY TERMINATION

UBRERC Protocol Number Sponsor Protocol Number

Protocol Title


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

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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