Sit Vi itSite VisitClosing MeetingClosing Meeting

PresentationPresentation

Learning ObjectiveLearning Objective

• To provide surveyors & survey trainees with an overview of the characteristics & components of the site visit closing meeting presentationmeeting presentation

OutlineOutline• Closing Meeting Characteristicsg g

• Closing Meeting Presentation Templateg gPreliminaries Standard 1: EC/IRB Structure & CompositionStandard 2: Adherence to Specific PoliciesStandard 3: Completeness of the Review ProcessStandard 4: After Review ProcessStandard 5: Documentation & ArchivingPost-Site Visit Activities

Closing Meeting CharacteristicsClosing Meeting Characteristics

• At the end of the site visit, the survey team conducts a closing meeting with g gthe EC/IRB representatives (Chair, members & staff)members & staff)

• The closing meeting is an opportunity ffor the survey team to thank the EC/IRB for their assistance & contribution during the survey

Closing Meeting CharacteristicsClosing Meeting Characteristics

• The closing meeting is an opportunity to present a summary report of the p y psurvey findings based on the five SIDCER standards (prepared by the surveySIDCER standards (prepared by the survey team, finalized by the lead surveyor & presented by the local surveyor)y )

• The closing meeting is an opportunity to discuss the survey findings withto discuss the survey findings with the EC/IRB

Closing Meeting CharacteristicsClosing Meeting Characteristics

• The closing meeting is an opportunity to explain the procedures & timeline p pfor the succeeding survey activities

Site Visit Closing Meeting-- Name of EC/IRB --

FERCAP Survey Teamdd/mm/yyyy

Survey TeamSurvey Team

• Survey Coordinator: • Local Survey Coordinator:Local Survey Coordinator: • Lead Surveyor:• Foreign Surveyor: • Local Surveyor:• Local Surveyor:

Survey TraineesSurvey Trainees• Group 1:• Group 1:

• Group 2:

• Group 3:

Survey ObjectiveSurvey ObjectiveTo assist the Name of EC/IRB in its quality development via reviewing its ethical review practices & appraising its performance vis à vis the SIDCER criteria for recognitionperformance vis-à-vis the SIDCER criteria for recognition.

Survey MethodologiesSurvey Methodologies• Office visit – Date & time• Review SOPs – Version & number of SOPs• Review protocols – Code numbers

Survey MethodologiesSurvey Methodologies• Document review – Membership files, Meeting

minutes, SAE files, Communication records• Board Observation – Date & time• Interview – Dates Group 1: Names & designation Group 2: Names & designation Group 3: Names & designation

Survey FrameworkSurvey Framework

• International Guidelines• National Guidelines • Vision-Mission of Name of EC/IRB• EC/IRB SOPs• SIDCER Survey SOPs

SIDCER CriteriaSIDCER Criteria• EC/IRB structure & composition• Adherence to specific policies• Completeness of review procedures• After review process• Documentation & archiving

Standard 1EC/IRB Structure & Composition

1. EC/IRB Structure & Composition

• Membership requirements• Administrative requirements• Membership initial & continuous training • EC/IRB office• Confidentiality agreement & management of conflicts

of interest

From what sources & forms do we get the ginformation for this criteria?

Membership files (#08), SOPs (#09), Interview (#10), Office visit (#07)

1. EC/IRB Structure & Composition

G d tiGood practices• The EC/IRB has a clear organogram detailing the

structure of the EC/IRB & its relationship with thestructure of the EC/IRB & its relationship with the hospital & medical university

• All EC/IRB members have appointment papers• All EC/IRB members have appointment papers• The EC/IRB has adequate number of administrative staff• All EC/IRB members have health research ethics GCP• All EC/IRB members have health research ethics, GCP

& SOP trainings• All EC/IRB members signed a confidentiality agreementAll EC/IRB members signed a confidentiality agreement

& declared that they don’t have any conflict of interest

1. EC/IRB Structure & Composition

RecommendationsRecommendations• Increase the number of women members in the EC/IRB• Appoint a pediatrician as EC/IRB memberpp p• Appoint a psychiatrist as EC/IRB consultant• Ask EC/IRB members to submit updated & signed CVs• Clarify the distinct roles of the Secretaries in terms of

EC/IRB operations• Provide a specific job description for each of theProvide a specific job description for each of the

administrative staff to define the scope their EC/IRB functions

Standard 2Adherence to Specific Policies

2 Adherence to Specific Policies2. Adherence to Specific Policies• Management of EC/IRB• Availability of SOPs• Areas & functions covered by the SOPs• Continuous review of SOPs• Guideline for protocol submission• Adherence to national & international guidelinesg

From what sources & forms do we get theFrom what sources & forms do we get the information for this criteria?

SOPs (#09), Interview (#10), Membership (Training) files (#08)

2 Adherence to Specific Policies2. Adherence to Specific PoliciesGood practicesGood practices• EC/IRB has comprehensive SOPs covering the

characteristics, functions & processes of the EC/IRB• EC/IRB SOPs are updated• EC/IRB checklists & forms are available

R l t i t ti l & ti l id li id tifi d• Relevant international & national guidelines are identified in the EC/IRB SOPs

• Generally, EC/IRB members & administrative staff know y,their SOPs

2 Adherence to Specific Policies2. Adherence to Specific PoliciesRecommendationsRecommendations• Improve the gender ratio in each panel (cf. SOP 05 -

35.1, page 12)• Delete the statement that an EC/IRB member who is

absent can transfer his/her right to vote to another EC/IRB member (cf. SOP 07 - 39.4, page 18)EC/IRB member (cf. SOP 07 39.4, page 18)

• Define the role of the pharmacist in SAE review (cf. SOP 11 - 45.5, page 25)

St d d 3Standard 3 Completeness of the ReviewCompleteness of the Review

Process

3. Completeness of the Review Process

• Review process• Elements of review• Decision-making process

From what sources & forms do we get the information for this criteria?

SOPs (#09), Protocol files (#11 & #12), Board observation (#15), Meeting minutes (#13), Interview (#10)

3. Completeness of the Review Process

Good practicesGood practicesBoard Meeting• Board Meeting has an agenda that the EC/IRB followsg g• Quorum is determined & met• Primary reviewers are appointed to review protocols• Non-medical members make relevant comments• Summary of revisions are projected on the screen for the

EC/IRB members to approveEC/IRB members to approve

3. Completeness of the Review Process

RecommendationsRecommendationsBoard Meeting• Conduct a comprehensive discussion of the ethical p

issues (confidentiality, risks, vulnerability, etc.) by commenting on the ethical items in the assessment form (e.g. Protocol CC-12-052 & Protocol CC-12-055)(e.g. Protocol CC 12 052 & Protocol CC 12 055)

• Consistently check the GCP training of the PI (e.g. Protocol CC-12-055 & Protocol CC-12-059) Id tif th EC/IRB b ith fli t f i t t &• Identify the EC/IRB member with conflict of interest & state in the meeting minutes that he left the room (e.g. CC-12-059)

3. Completeness of the Review Process

Good practicesGood practicesProtocol File Review• Assessment forms are used by reviewersy• Scientific & technical issues are reviewed• Informed consent form is reviewed

3. Completeness of the Review Process

RecommendationsRecommendationsProtocol File Review• Require evidence of GCP training for PIs (e.g. CC-09-q g ( g

085, CC-10-054)• Comment on the risks & vulnerability in the assessment

forms (e g CC-10-007 CC-11-010)forms (e.g. CC-10-007, CC-11-010)• Specify in the informed consent form the type of sample

or specimen to be taken from the participant for the ti t d ( CC 11 017)genetic study (e.g. CC-11-017)

St d d 4Standard 4After Review ProcessAfter Review Process

4 After Review Process4. After Review Process• Minutes• Amendments• SAE reports & site visits• Progress reports & final reports

From what sources & forms do we get the ginformation for this criteria?

SOPs (#09), Protocol files (#11 & #12), Meeting minutes (#13), SAE reports (#14) Interview (#10)(#14), Interview (#10)

4 After Review Process4. After Review ProcessGood practicesGood practices• EC/IRB tracks the status of continuing review reports in

the database• SAE reports are reviewed during the expedited meeting

& meeting minutes are kept• Progress & final reports are required by the EC/IRB• Progress & final reports are required by the EC/IRB

4 After Review Process4. After Review ProcessRecommendationsRecommendations• Consistently review, approve & file protocol & informed

consent form amendments (cf. CC-10-010, CC-11-017)• Review, classify & summarize SAEs according a) to site

where they happened (foreign, local, onsite); b) relatedness; c) unexpectedness (SUSAR) (cf. CC-10-relatedness; c) unexpectedness (SUSAR) (cf. CC 10010, CC-11-023)

• Check the need to conduct site visit of PI (for cause or routine) (cf CC 10 010 CC 11 017)routine) (cf. CC-10-010, CC-11-017)

• Require PIs to use the progress report form & final report form CF to summarize patient recruitment to the EC/IRB ( f CC 11 002)(cf. CC-11-002)

Standard 5Standard 5Documentation & ArchivingDocumentation & Archiving

5 Documentation & Archiving5. Documentation & Archiving• Documentation• Communication records• Retrieval procedures• Archiving

From what sources & forms do we get the ginformation for this criteria?

SOPs (#09), Office visit (#07), Interview (#10), Protocol files (#11 & #12), Meeting minutes (#13) Membership files (#08) SAE reports (#4)Meeting minutes (#13), Membership files (#08), SAE reports (#4), Interview (#10)

5 Documentation & Archiving5. Documentation & ArchivingGood practicesGood practices• Confidentiality of documents are maintained• International & national guidelines are available& g• SOPs are available• Membership files are well-organized• Communication files are available• Active & completed protocol files are separated• Coding system for protocol files is used• Coding system for protocol files is used• Database is maintained & secured• Website is functional & provides the necessary informationp y

5 Documentation & Archiving5. Documentation & ArchivingRecommendationsRecommendations• Make the flowcharts bigger• Include continuing review in the flowchartg• Prepare a table of contents for each protocol file• Add additional columns in the summary database which

f l f it i d t b i iare useful for monitoring document submission

Post Visit ActivitiesPost-Visit Activities• Visit Certification from SIDCER• Finalization of Survey Report by the survey team

S b i i f S R t t F S t i t• Submission of Survey Report to Forum Secretariat 3 weeks after the survey visit (by Date)C id ti f th S R t b th SIDCER• Consideration of the Survey Report by the SIDCER Committee

• Communication with EC/IRB: Findings &• Communication with EC/IRB: Findings & recommendations for recognition, follow-up action or a follow-up visit (by Date)

• EC/IRB reply to FERCAP within 30 days (by Date)

After RecognitionAfter Recognition• FERCAP Institutional Membership • Annual report & annual membership fee ($300)

Att d f FERCAP l f• Attendance of FERCAP annual conference• Support for country FERCAP surveys

P ti i ti i l t d FERCAP ti iti• Participation in related FERCAP activities