BC Clinical Research Infrastructure Network

BC Clinical Research Infrastructure Network BCCRIN Changing the landscape for clinical research in BC. www.bccrin.ca

Lunch and Learn SeriesAudit and Inspection Preparedness Program

LL #1 Long Term Preparations

Agenda • AIPP Program • Session Objectives • Types of Audits • Who Audits and Why • Selection Criteria • 10 things to Do for Long term preparedness • Questions and Answers

Audit Inspection Preparedness Program (AIPP) It approaches quality and compliance through audit education and planning. Research staff have access to: • training session • mock audit exercises • written resource • opportunity to develop long term and short term preparation compliance plans

Objectives of the Session Increase research team’s comfort with preparing for an audit Promote compliance Introduce compliance management and quality management concepts

Types of Audits Routine or Random Targeted or Directed For Cause Auditors and regulatory authorities also do Verifications. Regulatory authorities do Investigations.

Who Audits? Regulatory - Domestic (Inspection) Qualification REB Vigilance Sponsor (pre, during, EOS, data) Internal or Institutional Foreign Joint Foreign

Why do they Audit Ensure participants safety and rights are protected Ensure quality integrity and accuracy of data Ensure compliance with regulations, institutional policy, best practices, industry standards and institutional expectations, REB requirements

Selection Criteria All agencies that audit have a policy or a manual that outlines their selection criteria. There is a full description of common selection criteria in the AIPP Manual.

10 Things to Do to for Audit Preparedness

1. Long Term Audit Preparation Plan Document – checklist format outlining long range preparation items Reviewed 3 to 6 months Class: working internal document

2. Compliance Education In order to be prepared you need to know what you are supposed to be compliant with: • Regulations (research and privacy) • Policies (institution, granting agencies, REB) • SOPs • Jurisdiction(s) • Current Guidance Documents • Audit trends

Compliance Post external audit or inspection or investigation is not a good time to discover that you are non compliant. Complacency is another issue that arises.

Compliance Education Mentorship Training - Initial and Ongoing • Division 5 (Canada) • Specialty subsection (medical device, biologics, radiopharmaceutical, combination products) • Canadian regulatory environment • GCP update annual with audit trends • Documented training on study area

Compliance Training Courses through BCCRIN • CITI Certification • SoCRA • ARCP TCPS Training (required for studies sponsored by CIHR etc) US, EU, Japan Regulatory Environment Country Specific GCP Training

3. Standard Operating Procedures SOP for each procedure conducted at your site or organization Policies , working practices, forms, and templates to support SOPs Missing SOPs that have been identified should be noted in a Compliance Development Plan (CPD)

4. Controlled Document Listings Listing (index) of all current controlled documents Most auditors will request this before an audit All obsolete SOPs, policies, WP’s, forms and templates should be listed as well The listings should include: • Title • Number (if applicable) • Version • Effective/Obsolete Date

5. Quality Systems Quality Systems should be in place, maintained and functional. • Document Management (Overview, CC, Annual Review, External Distribution, External Document Registration) • Training • Deviation, CAPA, Observation • CQI • Auditing, Vendor Qualification

6. Collection/Location of Documents Determine whether there are any pertinent documents located off site or in other offices. Examples of documents commonly missing: • Statements of Compliance (i.e. computerized systems) • Validation Documentation • Security Documents (reasonable protection of study)

Collection/Location of Required Documents • Reports – can you provide them on short notice (arrange for programming) • Transfer of Responsibility document • Closed study documentation (logged and obtainable) • Audit History • Study Signature Sheets • Access Logs (guest registry, restricted rooms, computers)

7. Items for Demonstration Areas that needs the most advance preparation Consider what an auditor will want to see Review your procedures/systems/processes Identify the items that would likely need to be demonstrated to prove that they are effective and function as they should. Select samples to show your system is effective. Write them down.

Items for Demonstration Examples: • Data Management Procedures • CQI system • Deviation/CAPA System • Handling of Investigational Product • Administration of Informed Consent • Audit Trail • Privacy Impact Assessments – data flow component

8. Audit Kit Prepare an Audit Kit so that you have the materials ready to conduct an audit at any time. Assign someone to be responsible to check the kit at least twice per year. Make sure that all current editions and recently updated items listed are added to the kit.

Audit Kit Items to put into your Audit Kit: • Contact Numbers for persons that need to be notified of the audit (management, sponsor, medical records, communications, QA, storage) • Welcome procedures (how to take credentials and do a guest registration) • Roles of Audit Personnel • Form & Instructions for Document and Record Control

Audit Kit Items to put into your Audit Kit Cont’: • Organizational Chart (current & past versions) • Site map (current and past versions of all locations) • Site or Research Team History (brochure or write-up) • Audit History • Disposable Camera • Pens (6) Black or Blue, indelible ink • Lined Notebooks for Facilitator and Scribe (6)

9. Audit Training Review the audit team member roles Review the rules of audit conduct. All personnel should be trained in audit conduct and the major Do’s and Don’ts Review the audit process and four phases (readiness, preparation upon notice, hosting an audit and audit follow-up)

10. Compliance Assessment Internal Audit/Review Compliance Review with a Compliance Specialist These types of reviews are educational in nature. Reports from an internal audit or compliance review will assist you to develop compliance development plan (CDP)

Compliance Development Plan (CDP) Prepare CDP to address anything idenfied in a compliance assessment: Identify items missing or requiring revision • Date entries • Title • Expected date of completion • Person responsible Identify any new Training requirements Can work in conjunction with a Long Term Audit Preparation Plan

Thank You --- Questions and Answers

Prepared for BCCRIN by: Jean SmartSmart QAS3375 West 26th AvenueVancouver, BCV6S 1N4Ph. 604-612-6372 email jesmart@telus.net

BC Clinical Research Infrastructure Network BCCRIN Changing the landscape for clinical research in BC. www.bccrin.ca

Lunch and Learn SeriesAudit and Inspection Preparedness Program

LL #2 Preparations Upon Notice of Audit

Agenda Introduction • AIPP Program • Session Objectives • Short Term Preparations • Questions and Answers

Objectives of the Session Increase research team’s comfort with preparing for and hosting an audit Promote compliance Introduce compliance management and quality management concepts

Confirmation of Notice Train your reception staff to know who they should put an auditor in touch with if one calls (the Host or Investigator). Confirm the audit date and make a note of it. You may be able to negotiate the date a little if it is a sponsor or a qualification audit as there is often three or four weeks notice. You will get one or two weeks notice for most other audits.

Confirmation of Notice When confirming an audit date, be bold and confident and ask for: • The purpose of the audit • The scope of the audit • The areas for review • An agenda If it is notice of a regulatory audit, the initial phone call may be your only chance to obtain any information about the audit, so ask then.

Designation of Audit Personnel Audit Host (aka Facilitator): • Calm, organized, articulate, the person that can lead your group through an audit • Regulatory Audit – Person should know the organization/site, systems and procedures well • Study related audit – Person familiar with the study, TMF/SMF and the systems & procedures that you have

Designation of Audit Personnel Role of the Audit Host: • Acts as contact at time of notice • Liaises with the auditor pre-audit as necessary • Attends the opening and exit meetings • Notes all document requests • Notes all topics and question areas • Ensures that all questions are answered • Conveys information to staff and administration at the end of each audit day

Designation of Other Audit Personnel Document Manager: • Controls documents during an audit Scribe (for Regulatory Audit or for cause audit): • Records all conversations, requests, topics of inquiry, unanswered questions • Accompanies Facilitator and Auditor • Also used for Exit Meetings

Designation of Audit Personnel QA or Compliance Specialist: • Consider the need (first audit, major qualification audit, regulatory audit, back to back audit, for cause audits, no notice, joint foreign inspection, investigation) Write down the Roles and outline of the duties.

Inform Inform those who need to know that there is an audit scheduled: • Management/Administration/Institution Rep • QA • Sponsor • REB/IRB • Medical Records/Off Site Storage Facility • IT Department/Security • Monitor

Team Meeting Host calls a meeting to get organized Inform staff about the purpose and scope of the audit Review your Audit Preparedness Plan Identify what still needs to be done based on the scope and purpose in the time available Assign someone to each task. Write out a checklist and ensure tasks are completed

Priorities Book Rooms Phone and photocopier Review the pertinent files (study) Review the TMF or SMF and Essential Documents Review your sample demonstration outlines and rehearse if necessary Prepare your controlled document listings and make sure they are up to date

Priorities Cont’ Reports – run them the day before if possible or alert the IT group that they may be needed Check that all training files are up to date • Signed at dated CV and qualification certificates • Signed job description (current and old) • Complete training records Retrain staff on audit conduct and audit procedures Practice with people likely to be interviewed

Priorities cont’ Check quality systems Check location of validation documentation and make sure it is in order (all binders accounted for) Check that controlled document binders/folders are all in order (current and obsolete SOPs etc) Check that the Audit Kit is up to date

Office preparation Do a walk through spot check of the general office • Clean up • Do filing File/Records room • Locked cabinets • Everything put away • Sign in/Sign out sheets in order • Label covers on file cabinets etc

Office Preparation Server room and IT - sponsors • Visit it • Check logs • Make sure control reports have been run • Check tape and backup items have been logged

Final Meeting Have a final meeting to ensure everything on your checklist is done Review greeting and sign in procedures Provide a space for the auditors to work Prepare a place for your Document Manager to work Remember, you have some control

BC Clinical Research Infrastructure Network