Survey Methodology: Reviewing SOPsReviewing SOPs

Aphornpirom Ketupanya M DAphornpirom Ketupanya,M.D.

Protection of Subjects

SIDCER Recognition CriteriaStandard 1-Struc. & Comp.: Impend., Compete. Plural., trans.,

St d d 2 SOPCommittee

RulesStandard 2-SOPs: standardization, uniformity

St d d 4 Aft R iStandard 3-Review:

Rules

Standard 4- Aft. Review:Continuing Review

Standard 3-Review:Efficient, quality, compliance,

Capability, etc.Review

Standard 5-Documentation: EvidenceDocumenta

tion

OutlineOutline

Definition SIDCER StandardSIDCER Standard Essential Sections Forms and Checklists What to Look for？ What to Look for？ Completeness, Consistency, Compliance

3

SOP Definition

• Detailed written instructions in a certainDetailed, written instructions in a certain format that describe all activities and action undertaken by an organization toaction undertaken by an organization to achieve uniformity in the performance of a

ifi f tispecific function.

SIDCER StandardSIDCER Standard

• Standard II: ADHERENCE TO SPECIFIC POLICIES– Ethics Committee has appropriate

management and operational procedures formanagement and operational procedures for optimal and systematic conduct of ethical reviewreview

• Etc., ……

Essential SectionsEssential Sections

1 P1. Purpose2. Scope and Coverage3 Division of responsibility3. Division of responsibility4. Flow chart

5 Detailed instructions5. Detailed instructions6. Glossary

7 References7. References 8. Annex: Forms and Checklists

Forms and ChecklistsForms and Checklists1. Application Forms, e.g.pp , g

• Application Form for Ethical Review• Progress Report• Protocol Amendment Form

SAE R ti F• SAE Reporting Form• Close-out Form

2. Review Forms and Checklists, e.g.• Initial Review Form/ChecklistInitial Review Form/Checklist• Informed Consent Checklist• Protocol Amendment Review Form• SAE Review Form

Cl t R i F• Close-out Review Form3. Working Forms and Checklists, e.g.

• Protocol Submission Checklist• EC Review Decision LetterEC Review Decision Letter• Certificate of Approval

List of SOPsCompleteness

List of SOPsSection of each SOPContent of each SOP

Among SOPsSOP d F

Compliance with R l ti &G id li

ComplianceConsistencySOPs and Forms Regulation &Guideline

Compliance with SOPs

CompletenessCompletenessList of SOPs• Scope of SOPs

– Writing and revising SOPs– Forming Ethics Committees– Review Procedures

M it i P d– Monitoring Procedures– Meeting Preparation & Meeting Minutes– CommunicationCommunication– Management of Study Files– Auditing an ERB

CompletenessCompleteness

List of SOPs• Whether complete?• Whether complete?

– Depending on necessity– Refer to FERCAP SOPsRefer to FERCAP SOPs

It does not mean complete when you copy FERCAP SOP th th h d it d tFERCAP SOPs, on the other hand, it does not mean incomplete when list of SOPs does not cover all FERCAP SOPscover all FERCAP SOPs.

Standard Operating ProceduresStandard Operating Procedures

Instructions for IRB staff• How to process protocols from• How to process protocols from

submission to dispositionS h d li b d ti• Scheduling board meetings

• Reminds current staff, instructs new t ffstaff

Instructions for IRB board members

• Starts with governing regulations• Adds institutional policies • Adds committee interpretations that• Adds committee interpretations that

serve as precedents

Instructions for researchers• How to submit a protocol• How to submit a protocol• Relevant information on human subjects

t ti i tprotection requirements–Protocol template–Consent form templates

• Explanation of IRB review processExplanation of IRB review process• Make widely available

CompletenessCompleteness

S ti f E h SOPSection of Each SOPs• Purpose• Scope and Coverage• Scope and Coverage• Division of responsibility• Flow chart o c a t

Detailed instructions• Glossary

R f• References• Annex: Forms and Checklists

This is almost compulsory.

CompletenessCompletenessContents of Each SOPs

Wh h t h h h ?• Why, what, when, who, how?• Criteria correct? Complete?• Reference documents used complete?• Additional consideration for specificAdditional consideration for specific

SOP?

ConsistencyConsistencyAmong SOPsg• Examples from survey finding

– One SOP mentions two weeks for expedited review, the other SOP mentions one week

– One SOP: Secretary decides if expedited review/full board review the other SOP: the Chair to decideboard review, the other SOP: the Chair to decide

– Expedited Review SOP not include SAE, SAE SOP says SAEs off-site be reviewed expedited

– Primary reviewer review progress report in one SOP, the other SOP says all progress report reviewed by member secretaryy

– Decision making category is not the same for each chapter of the SOP

ConsistencyConsistencySOPs and Forms• Examples from survey finding

– SOP define coding rule for Annex FormSOP define coding rule for Annex Form, the forms coded in a different way

– Coding of one form is different at differentCoding of one form is different at different place

• Attached Forms• Form in SOP• Form in Section of “Annex Form”

ComplianceComplianceCompliance with Regulation/Guideline

SOP li t ith ti l L d l ti ?• SOPs compliant with national Law and regulation?– Considering the coverage of EC review

• SOPs compliant with international guideline?D l ti f H l i ki– Declaration of Helsinki

– WHO guideline for EC– CIMOS guideline

ICH GCP– ICH GCP• SOPs compliant with institution policy?• Whether requirements of regulation/guideline

embodied in SOP?embodied in SOP?– Archiving duration, SAE reporting, ICF checklist, Initial

review consideration, etc.• The updated regulation and guideline used?The updated regulation and guideline used?

ComplianceComplianceCompliance with SOPsp• Do what you write, write what you do.• Protocols minutes agenda• Protocols, minutes, agenda,

membership file, COA, documentation, coding ALL AREAScoding, ALL AREAS.

Each document reviewed in survey, must refer to SOP.

SIDCER FERCAP Form009:SIDCER-FERCAP Form009: SOP Review ChecklistSOP Review Checklist

ContentContent

• Writing and Revising SOPs• Constituting an EC/IRBConstituting an EC/IRB• Protocol Review Process• Monitoring Protocol Implementation• Board Meeting• Board Meeting• Communication process• Management of Study Files

»Form