Alliance Audit Regulatory Review
Transcript of Alliance Audit Regulatory Review
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Alliance Audit Regulatory Review
Kurombi Wade-Oliver, BA, CCRPAlliance Chicago Office
November 1, 2018
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Presentation Objectivesl Identify the Regulatory Review Process and the
Documents that will be reviewed
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Presentation Objectivesl Identify the Regulatory Review Process and the
Documents that will be reviewedl Prior to the audit
l Protocols approved through the utilization of a local IRBl Protocols approved through the utilization of the CIRB
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Presentation Objectivesl Identify the Regulatory Review Process and the
Documents that will be reviewedl Prior to the audit
l Protocols approved through the utilization of a local IRBl Protocols approved through the utilization of the CIRB
l During the auditl Protocols approved through the utilization of local IRBl Protocols approved through the utilization of the CIRB
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Presentation Objectivesl Identify the Regulatory Review Process and the
Documents that will be reviewedl Prior to the audit
l Protocols approved through the utilization of a local IRBl Protocols approved through the utilization of the CIRB
l During the auditl Protocols approved through the utilization of local IRBl Protocols approved through the utilization of the CIRB
l Describe Common Regulatory Deficiencies found during an audit
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Presentation Objectivesl Identify the Regulatory Review Process and the
Documents that will be reviewedl Prior to the audit
l Protocols approved through the utilization of a local IRBl Protocols approved through the utilization of the CIRB
l During the auditl Protocols approved through the utilization of local IRBl Protocols approved through the utilization of the CIRB
l Describe Common Regulatory Deficiencies found during an audit
l How to Avoid Regulatory Deficiencies
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Regulatory Review
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Regulatory Review
l Regulatory review is the review of the foundation documents for conducting a particular study at your site.
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Regulatory Review
l Regulatory review is the review of the foundation documents for conducting a particular study at your site.l Two Step Process
l Pre-review l At time of audit
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Regulatory Review
l Regulatory review is the review of the foundation documents for conducting a particular study at your site.l Two Step Process
l Pre-review l At time of audit
l Three Partsl IRB reviewl Informed Consent Content Reviewl Delegation Task Log (DTL) if applicable
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Regulatory Review
l Regulatory review is the review of the foundation documents for conducting a particular study at your site.l Two Step Process
l Pre-review l At time of audit
l Three Partsl IRB reviewl Informed Consent Content Reviewl Delegation Task Log (DTL) if applicableNote: A minimum of 4 studies will be selected for review
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Step I: Regulatory Pre-Review
l Per CTMB guidelines section 4.2, the list of protocols and patient cases selected will be supplied to the site at least 2 weeks (no more than 4) prior to the audit
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Step I: Regulatory Pre-Review
l For each protocol selected for audit and consent content compliance the site will forward the following regulatory documents to the Chicago Office prior to the audit date
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Step I: Regulatory Pre-Review
l For each protocol selected for audit and consent content compliance the site will forward the following regulatory documents to the Chicago Office prior to the audit datel Initial (Final) IRB Protocol Approvall Continuing / Annual Renewal Approvals l Required Amendment / Update Approvalsl Selected Locally Utilized Informed Consent Form l Applicable Corresponding Model Consent
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Step I: Regulatory Pre-Review
l For each protocol selected for audit and consent content compliance the site will forward the following regulatory documents to the Chicago Office prior to the audit datel Trials reviewed under the CIRB
l Approval letter from CIRB noting acceptance as IRB of recordl Study specific worksheet with local contextl Selected locally utilized informed consent form l Applicable corresponding model consent
l All other CIRB approval documents will be reviewed at the time of audit
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Step I: Regulatory Pre-Review Part I: IRB Review
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Step I: Regulatory Pre-Review Part I: IRB ReviewWhat are Auditors looking for?
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Step I: Regulatory Pre-Review Part I: IRB ReviewWhat are Auditors looking for?
l Documentation of IRB Approval
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Step I: Regulatory Pre-Review Part I: IRB ReviewWhat are Auditors looking for?
l Documentation of IRB Approval l IRB Review Type
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Step I: Regulatory Pre-Review Part I: IRB ReviewWhat are Auditors looking for?
l Documentation of IRB Approval l IRB Review Typel Timing
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Part I: IRB ReviewInitial IRB Protocol Approval
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Part I: IRB ReviewInitial IRB Protocol Approval
What are we looking for?
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Part I: IRB ReviewInitial IRB Protocol Approval
What are we looking for?
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Part I: IRB ReviewInitial IRB Protocol Approval
What are we looking for?
l Approval date and signature by the Chair (or designee)
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Part I: IRB ReviewInitial IRB Protocol Approval
What are we looking for?
l Approval date and signature by the Chair (or designee)
l Full Board Review
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Part I: IRB ReviewInitial IRB Protocol Approval
What are we looking for?
l Approval date and signature by the Chair (or designee)
l Full Board Review l Approval was received
prior to patient enrollment
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Part I: IRB ReviewContinuing / Annual Reviews
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Part I: IRB ReviewContinuing / Annual Reviews
What are we looking for?
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Part I: IRB ReviewContinuing / Annual Reviews
What are we looking for?
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Part I: IRB ReviewContinuing / Annual Reviews
What are we looking for?
l Approval is < 365 days from last review/initial approval
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Part I: IRB ReviewContinuing / Annual Reviews
What are we looking for?
l Approval is < 365 days from last review/initial approval
l Full board reviewed for protocols w/ active recruitment or subjects on active treatment
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Part I: IRB ReviewRequired Amendments / Updates
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
l Approvals are obtained within 90 days of the group’s notification datel Alliance broadcasts occur on the 1st and 15th of the monthl CTSU broadcasts occur on the 8th and 22nd of the month
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
l Approvals are obtained within 90 days of the group’s notification datel Alliance broadcasts occur on the 1st and 15th of the monthl CTSU broadcasts occur on the 8th and 22nd of the month
l The IRB review is appropriate to the requirement (i.e. full board vs. expedited)
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
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Part I: IRB ReviewRequired Amendments / Updates
What are we looking for?
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Common IRB Major Deficiencies
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Common IRB Major Deficiencies
l Local IRB Oversight
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Common IRB Major DeficienciesUpdate 3, broadcast on 3/1/17, was submitted to the IRB. A review of documents revealed the site over looked the submission of update 2, broadcast on 12/15/16. The site informed the IRB. The IRB acknowledged the changes for update 2 incorporated in update 3, therefore update 2 was approved with update 3 on 5/5/17.
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Common IRB Major DeficienciesUpdate 3, broadcast on 3/1/17, was submitted to the IRB. A review of documents revealed the site over looked the submission of update 2, broadcast on 12/15/16. The site informed the IRB. The IRB acknowledged the changes for update 2 incorporated in update 3, therefore update 2 was approved with update 3 on 5/5/17.
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Common IRB Major Deficiencies
A study was submitted to the IRB for continuing review that would expire on 9/16/16. On 9/6/16 the site received contingent approval. The IRB required study clarifications. The study received full continuing review approval on 11/6/16.
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Common IRB Major Deficiencies
A study was submitted to the IRB for continuing review that would expire on 9/16/16. On 9/6/16 the site received contingent approval. The IRB required study clarifications. The study received full continuing review approval on 11/6/16.
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Common IRB Major Deficiencies
Local IRB Oversightl Amendment approvals obtained greater than 90
days post group’s notificationl Continuing review approved by expedited review
when full board review is neededl Expired continuing reviews greater than 30 days
late
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Common IRB Major Deficiencies
l CIRB Oversight
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Common IRB Major Deficiencies
Participant 987654 is enrolled to Alliance protocol A011106 for site US123. During the audit, the auditors note the participant was consented and enrolled at sub-affiliate/ component US124.
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Common IRB Major Deficiencies
Participant 987654 is enrolled to Alliance protocol A011106 for site US123. During the audit, the auditors note the participant was consented and enrolled at sub-affiliate/ component US124.
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Step I: Regulatory Pre-Review Part II: Informed Consent Content
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Step I: Regulatory Pre-Review Part II: Informed Consent Contentl A minimum of 4 consents will be selected for review
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Step I: Regulatory Pre-Review Part II: Informed Consent Contentl A minimum of 4 consents will be selected for reviewl For each consent selected the site will forward the
following to the Chicago Office prior to the audit date (including CIRB reviewed studies)
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Step I: Regulatory Pre-Review Part II: Informed Consent Contentl A minimum of 4 consents will be selected for reviewl For each consent selected the site will forward the
following to the Chicago Office prior to the audit date (including CIRB reviewed studies) l Current approved locally utilized informed consent forml Applicable model consent
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Part II: Informed Consent Content
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Step I: Regulatory Pre-Review Part II: Informed Consent Content
What are we looking for?
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Part II: Informed Consent Content
l Informed Consent Forms are reviewed for the 8 basic required elements of a consent (21CFR50.25)l Study involves research l Description of foreseeable risksl Description of benefitsl Disclosure of alternativesl Description describing confidentiality maintenancel Compensation / treatment in the case of injuryl Contact information for questions regarding research/rightsl Participation is voluntary
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Part II: Informed Consent Content
l Informed Consent Forms are reviewed for additionalelements (21CFR50.25)l Treatment may involve risks
l Anticipated circumstances in which subject’s participation may be terminated
l Additional costs to the subject
l Consequences for subject’s decision to withdraw
l Subject will be informed of significant new findings
l Approximate number of subjects
l A copy of this form will be given to the subject
l http://www.ClinicalTrials.gov website listed per U.S. law
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Part II: Informed Consent Content
CIRB Trials
Yes the informed consent form is reviewed!Because CIRB is the IRB of record your locally utilized consent must be a word for word match with the model consent with the exception of what is approved by the CIRB on the study specific worksheet with local context
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Informed Consent Content Common Major Deficiencies
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Informed Consent Content Common Major Deficiencies
l ICF missing any of the 8 required elements l Study involves research l Description of foreseeable risksl Description of benefitsl Disclosure of alternativesl Description describing confidentiality maintenancel Compensation / treatment in the case of injuryl Contact information for questions regarding research/rightsl Participation is voluntary
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Informed Consent Content Common Major Deficiencies
l ICF missing language from the additional elementsl Treatment may involve risksl Anticipated circumstances in which subject’s participation
may be terminatedl Additional costs to the subject l Consequences for subject’s decision to withdraw l Subject will be informed of significant new findings l Approximate number of subjectsl A copy of this form will be given to the subjectl http://www.ClinicalTrials.gov website listed per U.S. law
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Informed Consent ContentCommon Major Deficiencies
When reviewing a site’s ICF for an Alliance trial studying the effects of Cabozantinib in patients with Renal Cell Carcinoma, the auditor noted the addition of the risks Abdominal, oral, extremity, muscle and chest pain which were not listed in the model consent.
Deficienciesl Involves research, purpose,
duration of participationl Description of foreseeable /
unforeseeable risksl Description of any benefitsl Disclosure of alternative
procedures/treatmentsl Description of the extent of
confidentiality of recordsl Explanation of
compensation/ treatments available if injured
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Informed Consent ContentCommon Major Deficiencies
When reviewing a site’s ICF for an Alliance trial studying the effects of Cabozantinib in patients with Renal Cell Carcinoma, the auditor noted the addition of the risks Abdominal, oral, extremity, muscle and chest pain which were not listed in the model consent.
Deficienciesl Involves research, purpose,
duration of participationl Description of foreseeable /
unforeseeable risksl Description of any benefitsl Disclosure of alternative
procedures/treatmentsl Description of the extent of
confidentiality of recordsl Explanation of
compensation/ treatments available if injured
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Informed Consent ContentCommon Major Deficiencies
When reviewing the site’s ICF for a trial studying Lenalidomide in Multiple Myeloma, receiving CIRB Oversight, the auditor noted additional language throughout the consent form not found in the model or approved Boiler Plate Language.
Deficienciesl Failure to revise the ICF in
response to an NCI Action Letter regarding risks
l Significant or substantial changes to the consent form document deviating from the CIRB-approved Boiler
l ICF contains changes not approved by the IRB, including changes to questions.
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Informed Consent ContentCommon Major Deficiencies
When reviewing the site’s ICF for a trial studying Lenalidomide in Multiple Myeloma, receiving CIRB Oversight, the auditor noted additional language throughout the consent form not found in the model or approved Boiler Plate Language.
Deficienciesl Failure to revise the ICF in
response to an NCI Action Letter regarding risks
l Significant or substantial changes to the consent form document deviating from the CIRB-approved Boiler Plate language
l ICF contains changes not approved by the IRB, including changes to questions.
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Informed Consent Content Common Major Deficiencies
l Omission of one or more risksl Omission of one or more of the required informed
consent elementsl Changes to the following without Alliance approval
l Additions to the risksl Additions / Omissions to the list of alternative optionsl Changes to the translational research section (including
the questions)l Changes to the ICF without the IRB of record approval
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Step II: Regulatory Review at Time of Audit
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Step II: Regulatory Review at Time of Audit
l Review of regulatory approval documents for any unannounced protocols
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Step II: Regulatory Review at Time of Audit
l Review of regulatory approval documents for any unannounced protocols
l Review submission of unanticipated / IND reports per your IRB policy
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Step II: Regulatory Review at Time of Audit
l CIRB reviewed trials l Ensure amendments that included ICF changes are
implemented at your site within 30 days of CTSU posting
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Step II: Regulatory Review at Time of Audit
Part III: Delegation Task Log
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Part III: Delegation Task Log
l Review Delegation of Task Log (for applicable registration trials)
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Part III: Delegation Task Log
l Review Delegation of Task Log (for applicable registration trials)l To evaluate the roles and responsibilities of the individuals
contributing efforts to a clinical trial a DTL must be maintained
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Part III: Delegation Task Log
What are Auditors looking for?
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Part III: Delegation Task Log
What are Auditors looking for?
l Ensure all research staff and roles are identified
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Part III: Delegation Task Log
What are Auditors looking for?
l Ensure all research staff and roles are identifiedl Utilize the DTL during the patient case review to ensure
tasks performed during the clinical trial correlate with the DTL
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Delegation Task Log Major Deficiencies
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Delegation Task Log Major Deficiencies
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Delegation Task Log Major Deficiencies
While reviewing a patient case for Alliance registration trial A031203 the auditor noted documentation that the Data Coordinator conducted the consenting process with the participant. The consenting process is not a task listed for this staff member on the DTL.
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Delegation Task Log Major Deficiencies
While reviewing a patient case for Alliance registration trial A031203 the auditor noted documentation that the Data Coordinator conducted the consenting process with the participant. The consenting process is not a task listed for this staff member on the DTL.
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Step II: Regulatory Review at Time of Audit
l Resolve any regulatory and consent discrepancies found during the pre-review / time of audit
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Step II: Regulatory Review at Time of Audit
l Resolve any regulatory and consent discrepancies found during the pre-review / time of audit
l Assess any regulatory findings
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiency
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiencyl Major Deficiency
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiencyl Major Deficiencyl Lesser Deficiency
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiency: Any finding identified before or during
an audit that is suspected to be fraudulent activity (CTMB guidelines 5.1)
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiency: Any finding identified before or during
an audit that is suspected to be fraudulent activity (CTMB guidelines 5.1)
l Major Deficiency: A variance from the protocol-specified procedures or practices that makes the resulting data questionable
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Critical Deficiency: Any finding identified before or during
an audit that is suspected to be fraudulent activity (CTMB guidelines 5.1)
l Major Deficiency: A variance from the protocol-specified procedures or practices that makes the resulting data questionable
l Lesser Deficiency: Findings do not have a significant impact on the outcome or interpretation of the study
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Acceptable
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Acceptablel Acceptable, Needs Follow-up
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Acceptablel Acceptable, Needs Follow-upl Unacceptable
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Acceptable
l No deficiencies identifiedl Few Lesser deficiencies identified
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Step II: Regulatory Review at Time of Audit
l Assess any regulatory findingsl Acceptable
l No deficiencies identifiedl Few Lesser deficiencies identified
l Acceptable, Needs Follow-upl Any Major deficiencies identifiedl Multiple Lesser deficiencies identified
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Step II: Regulatory Review at Time of Audit
l Resolve any regulatory and consent discrepancies found during the pre-review / time of audit
l Assess any regulatory findingsl Acceptable
l No deficiencies identifiedl Few Lesser deficiencies identified
l Acceptable, Needs Follow-upl Any Major deficiencies identifiedl Multiple Lesser deficiencies identified
l Unacceptablel A single Critical deficiencyl Multiple Major deficiencies identifiedl Multiple Lesser deficiencies of a recurring nature
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How to Avoid Regulatory Deficiencies
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How to Avoid IRB DeficienciesGet Organized!
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How to Avoid IRB DeficienciesGet Organized!
l Create a separate chronological regulatory file for each protocol and each document typel Initial Final Approvall Continuing Reviewsl Required Amendments
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How to Avoid IRB DeficienciesGet Organized!
l Create a separate chronological regulatory file for each protocol and each document typel Initial Final Approvall Continuing Reviewsl Required Amendments
l Print, Flag and File approval documents ASAP!
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How to Avoid IRB DeficienciesGet Organized!
l Create a separate chronological regulatory file for each protocol and each document typel Initial Final Approvall Continuing Reviewsl Required Amendments
l Print, Flag and File approval documents ASAP!l Create a calendar for tracking regulatory deadlines
l Deadlines for protocol submissions to IRBl Reminders to check email/sponsor website on broadcast
dates
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How to Avoid ICC Deficienciesl Utilize the model consent as your local informed
consent form!l Copy the model word for wordl Insert local language where appropriatel Have a double check system of review
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How to Avoid ICC Deficienciesl Utilize the model consent as your local informed
consent form!l Copy the model word for wordl Insert local language where appropriatel Have a double check system of review
l The content of certain ICC sections should NEVERchange l Risk Listl Alternative procedures / treatment l Translational research section (wording/order of the
questions)
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How to Avoid ICC Deficiencies
l Contact the Alliance for approval for ICC changesl Risk Listl Alternative procedures / treatment l Translational research section l Changes that may alter the intent/methodology of the
study
l See Alliance Policy & Procedure section 2.8.7.2.2
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How to Avoid DTL Deficiencies
l Create a study specific DTL at the time of study activation
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How to Avoid DTL Deficiencies
l Create a study specific DTL at the time of study activationl List all pertinent research staff and assigned
rolesl Ensure PI signs and dates
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How to Avoid DTL Deficiencies
l Create a study specific DTL at the time of study activationl List all pertinent research staff and assigned
rolesl Ensure PI signs and dates
l Ensure the research staff is aware of their study specific tasks
l Keep the DTL up-to-date with research staff/role changes
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Conclusion:Regulatory Review
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Conclusion:Regulatory Review
l Regulatory review is a two step processl Pre-review (prior to the audit date)l Items reviewed at the time of the audit
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Conclusion:Regulatory Review
l Regulatory review is a two step processl Pre-review (prior to the audit date)l Items reviewed at the time of the audit
l Regulatory review occurs in three partsl IRB reviewl Informed Consent Content reviewl DTL review (for applicable registration trials)
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Conclusion:Regulatory Review
l Regulatory review is a two step processl Pre-review (prior to the audit date)l Items reviewed at the time of the audit
l Regulatory review occurs in three partsl IRB reviewl Informed Consent Content reviewl DTL review (for applicable registration trials)
l Common Major Deficiencies l IRB reviewl Informed Consent Content reviewl Delegation Task Log reviewl How to Avoid Deficiencies
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Website Resources
The Alliance for Clinical Trials in Oncologywww.allianceforclinicaltrialsinoncology.org
FDA Code of Federal Regulations https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Cancer Therapy Evaluation Program (CTEP)http://ctep.cancer.gov/branches/ctmb/clinicalTrials/docs/ctmb_audit_gui
delines.pdf
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THANK YOU!
l Questions from Audiencel Answers from Presenter