Pearls of Wisdom. Debra Herzan, Josh Lachewitz, Kurombi Wade-Oliver Alliance Chicago Office. May 2015
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1 Pearls of Wisdom Debra Herzan, Josh Lachewitz, Kurombi Wade-Oliver Alliance Chicago Office May 2015
2 Pearls of Wisdom: IRB Review l Kurombi Wade-Oliver, BA, CCRP l Alliance Clinical Trials Auditor l Alliance, Chicago Office
3 IRB REVIEW
4 IRB REVIEW CTMB Guideline 4.4 The institution is responsible for ensuring that all relevant materials are available for review at the time of the audit. IRB documents, copies of the locally utilized informed consent forms, other regulatory documentation, if applicable.
5 IRB REVIEW Alliance Policy Assessing Audit Findings An audit consists of reviewing and evaluating: Conformance to IRB and informed consent content requirements
6 IRB REVIEW CTMB Guidelines 5.2 Review of IRB Documentation and Informed Consent Content IRB For each protocol selected for an audit, the following documents should be the minimum items to be reviewed: Full Initial IRB approval AND Annual re-approval Approval (or disapproval) of protocol amendments that affects more than minimal risk Documentation of IRB approval or re-approval prior to patient registration l
7 IRB REVIEW PROBLEM # 1 IRB REGULATORY RECORDS l Incomplete l Difficult to track l CIRB regulatory records not available
8 PEARL
9 ORGANIZE!
10 PEARL: ORGANIZE! l Keep protocols AND documents separated l Create a separate folder / dividers Initial Approval Continuing Reviews Amendment Approvals
11 PEARL: ORGANIZE TIP! FLAG AND FILE As You Go! DON T WAIT for a notice of an audit.
12 PEARL: ORGANIZE TIP! FLAG AND FILE As You Go! FLAG and FILE each approval when it is received! For automated systems (Local and CIRB): PRINT, FLAG and FILE immediately!
13 PEARL: ORGANIZE TIP! On each FLAG write the following information v Initial Approval/ Amendment/ Continuing Review v IRB Approval/Acknowledgement Date v Protocol Version Date (if applicable)
14 PEARL: ORGANIZE TIP! ALTERNATIVELY Use the flagging system WITH a legend/log accessible in the front of the binder to identify IRB Correspondence
15 PEARL: ORGANIZE REMEMBER! CIRB: IRB of Record Per CTMB Guidelines 5.2 The following will need to be on file for review l Approval letter from the CIRB noting the local IRB accepts CIRB as the IRB of record l All CIRB approval documents l The study specific worksheet with local context
16 IRB REVIEW PROBLEM # 2 LATE SUBMISSIONS TO IRB
17 IRB REVIEW PROBLEM # 2 LATE SUBMISSIONS TO IRB CTMB Guideline Amendments (addendums or updates) must be approved by the IRB of record within 90 days of the Group s notification
18 PEARL
19 DOCUMENT TRACKING
20 PEARL: DOCUMENT TRACKING Conduct An Internal Audit of Protocol Document Submissions Monthly / Quarterly Keep a Running List of Required Approvals / Deadlines
21 PEARL: DOCUMENT TRACKING For automated systems / databases Create a report in your local database that can run tracking reports
22 PEARL: DOCUMENT TRACKING TIP! Highlight pertinent information Approval types Approval deadlines Review type for easy review/tracking
23 IRB REVIEW INFORMED CONSENT CONTENT
24 INFORMED CONSENT CONTENT CTMB Guidelines Each of the informed consent documents selected for audit must be reviewed to ensure they contain the risks and alternatives listed in the model informed consent document approved by the NCI.
25 INFORMED CONSENT CONTENT
26 INFORMED CONSENT CONTENT PROBLEM LOCAL CONSENT MISSING REQUIRED ELEMENTS
27 INFORMED CONSENT CONTENT PROBLEM Local Consent Missing Required Elements l Omitted Risks or Discomforts l Missing Statement of Unforeseeable Risks l Omitted / Changed Alterative Treatments l Missing Statement that new findings will be discussed l Omitted study correlative / study companion questions
28 PEARL
29 Duplicate Model Consent!
30 PEARL: Duplicate Model Consent! l Maintain the order and format of the Model Consent l Add specific institution information After ensuring Model Consent format is in tact
31 PEARL: Duplicate Model Consent! l Do NOT Omit Risks l Do Not Change Alternatives to Participation l Discourage your IRB from rearranging the order of the study specific sample questions
32 PEARL: Duplicate Model Consent! If CIRB is the IRB of Record The Local Consent should match the Model word for word
33 PEARL: Duplicate Model Consent! TIP! Cut and Paste from the Model Double check that adding does not omit
34 PEARL: Duplicate Model Consent! REMEMBER! If local IRB requires changes obtain Lead Center / Sponsor Approval FIRST
35 PEARL: Duplicate Model Consent! Alliance Policy Any substantive changes of information concerning risks or alternative procedures and/or translational research contained in the model informed consent document must be justified in writing by the Investigator. Investigators must forward copies of such changes, with their justifications, to the Alliance regulatory staff for review
36 PEARL: Duplicate Model Consent! REMEMBER! l Maintain a copy of Sponsor approved changes in the IRB binder l If CIRB is the IRB of record the study specific l worksheet with local context will need to be on file for review
37 Pearls of Wisdom: IRB Review Please save questions for the panel at the end of the presentations.
Pearls of Wisdom. Debra Herzan, Josh Lachewitz, Kurombi Wade-Oliver Alliance Chicago Office. May 2015
Pearls of Wisdom Debra Herzan, Josh Lachewitz, Kurombi Wade-Oliver Alliance Chicago Office May 2015 Pearls of Wisdom: IRB Review l Kurombi Wade-Oliver, BA, CCRP l Alliance Clinical Trials Auditor l Alliance,
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