Site visit closing meeting 30 october 2010
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Site Visit Closing Meeting 30 October 2010. Presented by Dr Anoja Fernando Lead Surveyor UP Philippine General Hospital ERB Survey 28-30 October 2010. Objective and scope of the survey. Objective: To evaluate the IRB for SIDCER recognition

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Site Visit Closing Meeting 30 October 2010

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Site visit closing meeting 30 october 2010

Site Visit Closing Meeting30 October 2010

Presented by Dr Anoja Fernando

Lead Surveyor

UP Philippine General Hospital

ERB Survey

28-30 October 2010


Objective and scope of the survey

Objective and scope of the survey

Objective: To evaluate the IRB for SIDCER recognition

Scope: the survey covers SIDCER recognition requirements:

Structure and composition of IRB

Adherence to specific policies

Completeness of its review process

Post-review procedures

Documentation and archiving


Sidcer surveyors

SIDCER Surveyors

Survey Coordinators

Juntra Karbwang (WHO-TDR)

Cristina Torres (FERCAP)

Foreign Surveyors

Anoja Fernando (Sri Lanka) Lead Surveyor

Magdarina Agtini (Indonesia)

Local Surveyor

Cecilia Tomas


Local trainees

Local Trainees

Dawn Quizon Moran


Survey objective

Survey Objective

To assistUP Philippine General Hospital ERB

in its quality development via reviewing its ethical review practices and appraising its performance vis-à-vis the SIDCER criteria for recognition.


Survey methodologies

Survey Methodologies

  • Office visit

  • Review SOPs – Chapters 1-10,Version 02, Aug 2010

  • Review protocols – 17

  • Document review – Membership files, complete meeting minutes not available, SAE files

  • Interviews

  • Board Observation – Friday 29 Oct 2010, 9am


Protocols reviewed

Protocols reviewed

  • 2010002

  • 023

  • 039

  • 045

  • 053

  • 063 079

  • 104

  • 111

    • 122

2008 012

034

039

2009027

056 087

014


Persons interviewed

Persons interviewed

EC Chairperson – Dr. Patricia Khu

EC Secretary – Dr Gemma Uy

Ms Daisy Manlangit

EC staff- Ms Eleanor Mercado

EC members (2-3)

Medical doctor/scientist

Dr Ryner Carrillo

Dr Jorge Ignacio

Lay person/non affiliated

Ms Edna Cunanan


Survey framework

Survey Framework

  • International Guidelines

  • National Guidelines

  • Vision-Mission of UP Philippine General Hospital

  • ERB EC SOPs

  • SIDCER Survey Program SOPs


Standard 1 irb structure and composition

Standard 1IRB Structure and Composition


1 irb structure and composition

1. IRB Structure and Composition

  • Membership requirements

  • Administrative requirements

  • Membership Initial and Continuous Training

  • Management of Conflicts


1 irb structure and composition1

1. IRB Structure and Composition

GOOD PRACTICES

Composition of ERB good (gender mix, expertise)

Office staff (3) knowledgeable and efficient

Members are appointed by the Hospital Director

Terms of reference are available

Conflict of interest documents are signed by majority of members

Members have initial and continuing training

Organizational chart is available

Highly qualified and competent officers

Dedicated and committed members


1 irb structure and composition2

Recommendations

Honorarium should be provided to members for reviewing protocols

Prepare a roster of independent consultants for expertise needed by the ERB

Recruit a member of Medicine department for Team B

Complete training records, confidentiality and COI, CVs for new staff and members

1. IRB Structure and Composition


Standard 2 adherence to specific policies

Standard 2Adherence to Specific Policies


2 adherence to specific policies

2. Adherence to Specific Policies

  • Management of IRB

  • Availability of SOPs

  • Areas and Functions covered by the SOPs

  • Continuous review of SOPs

  • Guideline for Protocol Submission

  • Adherence to national and international guidelines


2 adherence to specific policies1

2. Adherence to specific policies

Good practices

SOPs have been revised (2008, 2010)

SOPs have been signed and approved

SOPs are available to all members

Comprehensive SOPs to cover major areas of operation

International, national and institutional guidelines are available in the office


2 adherence to specific policies2

2. Adherence to specific policies

Recommendations

  • Improve formatting of SOPs:

    • Include history of SOP for each chapter

    • Use third person consistently

    • Chapter number with title

    • Check inconsistencies between the flow chart and detailed instructions (Chapter 2.3)-

      Add SOP training to topics for training (p 21)


2 adherence to specific policies3

2. Adherence to specific policies

  • Recommendations

  • Complete sections of SOPs:

    • 2.1 (Constituting ERB) Add responsibilities of members

    • 8.2 (Preparation and Conduct of Meetings) Add and define quorum requirements for the meeting

    • Prepare an assent form template to assist investigators to prepare one.

    • 3.1 Prepare an application form to provide standard information to the ERB


2 adherence to specific policies4

2. Adherence to specific policies

Recommendations

  • Use correct terminology in SOPs:

    • 6.3.1 Board A and B (instead of Team A and B)

    • 6.3.1 -Delete ‘consensus’ meeting and ‘consensus’ form. Restate the function of Board Secretary (Team Secretary)

    • 6.4 – ERB Secretary name should be distinguished from Board Secretary

    • Form 8.2 – Revise to conform with the form currently used and change ‘consensus’ to Board decision

    • Review consensus procedures during board meeting

    • 3.2 – (page 34) 9 – “recommendation” instead of “decision “protocol evaluation form” not “decision form”.

      “Board” meeting not “team” meeting.


2 adherence to specific policies5

2. Adherence to specific policies

  • Recommendations

    8.2 – Clarify how COI of board member is managed during the meeting (joining discussion and consensus building, p.76-77)

    3.1 – Mention electronic database entry of submitted protocols

    6 – Introduce the concept of SUSAR in SAE management

    Provide instructions about ERB management of SAE reports

    Include local guidelines in the list of references


Standard 3 completeness of the review process

Standard 3. Completeness of the Review Process


3 completeness of the review process

3. Completeness of the Review Process

  • Review Process

  • Elements of Review

  • Board Meeting

  • Completeness of IEC/IRB Meeting Minutes

  • Decision Making Process


3 completeness of the review process1

3. Completeness of the Review Process

Good Practices

  • Use of expedited and full board review procedures

  • Assessment forms available

  • Use of 2 primary reviewers for expedited and 3 for full board (medical and non medical)

  • Sufficient time for members to prepare for review

  • Regular meetings are held and schedule is set

  • Good attendance during meetings

  • Technical and ethical issues are raised

  • Reviewer Assessment forms are submitted to the board secretary before the board meeting


3 completeness of the review process2

3. Completeness of the Review Process

Good Practices

Good discussion of issues during the board meeting

Chair facilitated interview with PI well

Investigators learn from the comments made by board members and are made aware of proper safeguards

Lay persons contributed to a good discussion

Agenda and minutes are available

Real time recording of the minutes on the template

Technical and ethical issues are discussed

Agenda and minutes are available


3 completeness of the review process3

3. Completeness of the Review Process

Recommendations

Protocol review

  • Reviewers should make comments on the various points in the assessment form (design, risks, vulnerability, etc.)

  • Make a vulnerability assessment about the type of participants used and recommend measures to protect them

  • Improve risk assessment and consider not only the physical risk related to intervention but risks involved when using patients with serious illness and chronic diseases


3 completeness of the review process4

3. Completeness of the Review Process

Recommendations

Board Meeting

Standardize the summary presented by the reviewer (objectives, methods, outcomes, etc.) to enable other board members to better understand the issues

Organize the discussion during board review and group issues systematically (technical, ethical, ICF)

Improve the review of ethical issues and comment about risks, vulnerability, etc.(+Cristina’s suggestion)

Send the agenda with summaries of protocols before a board meeting for other members to prepare comments

Send the minutes of the previous meeting approximately one week before the meeting for the board members to review and make comments and facilitate approval during the meeting


3 completeness of the review process5

3. Completeness of the Review Process

Recommendations

Board Meeting

Refer to international and national guidelines when discussing ethical issues (e.g. use of placebo and Declaration of Helsinki)

Revisions required should be clearly summarized at the end of the discussion of each protocol


3 completeness of the review process6

3. Completeness of the Review Process

Recommendations

Improve the minutes of the meeting

Focus on issues discussed and organize the discussion into themes, rather than presenting a transcript of comments

Signatories should indicate the date when they sign the minutes

Check the inconsistencies between risk assessment and comments made by reviewers

Separate expedited review list into 2 sections, initial review and review of revisions

Check inconsistency between attendance list and names of reviewers in the discussion section

Change ‘Consensus’ to Board Decision

Record only what is discussed during the meeting (Exclude comments sent earlier by reviewers)


Standard 4 after review process

Standard 4: After Review Process


4 after review process

4. After Review Process

Approval letter and communication with investigators about board action

Submission of reports

Progress

Final

SAE

Site visit

Response to participant queries


4 after review process1

4. After Review Process

Good practice

  • Communication of board action sent promptly to the investigators

  • Approval letter states the responsibilities of the investigator after approval of the protocol

  • Site visit was done

  • Final reports are required before clearance of trainees


4 after review process2

4. After Review Process

Recommendations

  • Improve the approval letter to state:

    • Date of board meeting

    • Version and date of documents (protocol, ICF, advertisement) approved

    • Annual progress report

  • Inform and educate investigators about possible SAEs when dealing with high risk patients (ICU. renal failure, neonates, etc.) and their responsibility to report them even if unrelated


4 after review process3

4. After Review Process

Recommendations

Improve Form 6.0 (SAE Report) to include a section of investigator SAE assessment (expected, unrelated)

Communicate with investigators to follow up final reports

Continuing review (progress, final reports, etc.) should be done at least once a year for approved protocols. (Do not say ‘no continuing review’)


Standard 5 documentation and archiving

Standard 5Documentation and Archiving


5 documentation and archiving

5. Documentation and Archiving

Good practice

  • Office files are secure and kept under lock and key

  • Active files are separate from completed files

  • Office space is adequate

  • Database is available

  • Sufficient equipment to support EC functions

  • Back up for database is done regularly


5 documentation and archiving1

Recommendations

Prepare bigger flow charts to better inform the investigators

Organize the protocol files:

Use binders

Prepare a table of contents for each file according to SOP

Complete the contents of the protocol file to indicate the dates of submission.

5. Documentation and Archiving


Post visit activities

Post-Visit Activities

  • Visit Certification from FERCAP

  • Finalization of Survey Report by the Team

  • Submission of Report to Forum Secretariat

    after the survey visit (by 10 November)

  • Consideration of the report by the SIDCER Committee

  • Communication with EC: Findings and recommendations for recognition, follow-up action or a follow-up visit (by 15 November)


Site visit closing meeting 30 october 2010

Thank You!


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