Health Canada s GCP Compliance Program Part 2. GCP Information Sessions November 2010

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1 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program Part 2 GCP Information Sessions November 2010

2 Inspection Program Main objectives of clinical trial inspections: Protection of subjects enrolled in clinical trials; Increase confidence that the data collected and subsequently submitted to Health Canada is valid; and Verify compliance to Division 5 of the FDR which includes the principles of Good Clinical Practices (GCPs).

3 Inspection Strategy for Clinical Trials (POL-0030) Inspections are conducted under the authority of section 23 of the Food and Drugs Act. Two phases to the implementation of inspections: A confidence building and voluntary phase; A final implementation phase.

4 Inspection Strategy for Clinical Trials (POL-0030) Average time of 5 days per inspection; 1 or 2 inspectors per inspection; Inspections are scheduled and announced The notification occurs a minimum of 5 days before the inspection is conducted; The notification is also sent to the Sponsor. Unannounced inspections may be conducted when deemed necessary.

5 There are seven (7) basic stages to an inspection: Preparation Opening meeting Inspection Report writing Exit interview Final Exit Notice Follow-up (if needed)

6 Preparation () Determine inspection team, scope, dates; Develop inspection plan; Review relevant information; Letter of no objection issued by Health Canada Study protocol and amendments Informed Consent Form and amendments Investigator s brochure Case Report Form

7 Preparation (Inspected party) Ensure access to a room with restricted access that is able to be locked; Ensure sufficient work space with access to a photocopier; Ensure availability of all records, including source medical records; Ensure ready access to staff, committee members.

8 Opening Meeting Key study personnel Purpose, scope and inspection plan Sponsor information Manufacturer, suppliers, CRO, SMO, monitors, auditors, laboratories REB information Work schedule Availability of all records

9 Inspection Site tour Interviews HC authorization/correspondence REB approvals/correspondence Informed consent Procedure Contents REB approval 100% check for signature

10 Inspection (cont d) Adherence to protocol Adherence to other procedures Training Drug quality Drug accountability and disposition Adverse event (AE) reporting Verification of source data reported on Case Report Forms (CRFs)

11 Report writing Observations are recorded and assigned a risk in accordance with Guide 0043: Classification of Observations Made in the Conduct of Clinical Trials; The observations are classified as "critical" (risk 1), "major" (risk 2) or "minor" (risk 3); Definition of critical observation: Observation describing a situation that results in fatal, life threatening or unsafe conditions for subjects enrolled in a clinical trial. It presents an immediate or latent undue risk to the rights, health and safety of subjects.

12 Report writing (cont d) Definition of major observation: Observation describing a marked deviation or deficiency, other than a critical one, that may result in undue health risks to the clinical trial subjects, in other persons or could invalidate the data. Examples of major observations: Failure to report a REB that previously refused to approve a trial. Informed consent not obtained from subjects before enrolment in the trial or after major amendments to the ICF.

13 Report writing (cont d) Definition of minor observation : Observation that is classified as not critical or major, but which indicates a deficiency and/or deviation from Division 5. Examples of minor observations: Date for the commencement of a clinical trial was earlier than that stated in the application. Delay in written notification by the sponsor within fifteen days after the date of the change that requires notification. Minor errors in transcribing data from source documents to case report forms.

14 Report writing (cont d) Based on the observations, an overall rating assigned ( Compliant or Non Compliant ); One or more critical observation will likely result in the attribution of a "NC" rating. Repetition of most major observations reported during previous inspections will likely result in the attribution of a NC rating. A "C" rating will be assigned in all situations when minor observations are noted.

15 Exit Interview The draft Inspection Exit Notice is issued which includes all observations and the overall rating; An opportunity is provided to respond to the observations and/or provide clarification; The dispute resolution and appeal mechanism is discussed; Corrective actions taken during the course of the inspection are verified and acknowledged.

16 Final Exit Notice Includes information about the site profile, officials, product in the trial, protocol title/number; Observations are listed and a response to each is required within a specified timeframe; The final rating ( C or NC ) is assigned; If a NC rating is assigned: Inspection findings are discussed with the relevant review Directorate; Action to be taken may include suspension or cancellation of the clinical trial.

17 Compliance Verifications/Investigations Triggered when a complaint is received; internal or external sources Are given a priority as they may reveal increased health risks; Can result in compliance actions; public advisories, warnings, quarantine, recalls For clinical trials, could result in stopping enrolment or discontinuation of trial.

18 Inspection Findings Inspection Program Review ( ) \ \ \ \ \ \ /09

19 Inspection Findings (cont d) Inspection Program Review ( ) Section of the Regulations (Description) % C (Good Clinical Practices) 62.2% C (Records) 20.5% C (Definitions) 11.3% C (Labelling) 3.2% C (Application for Authorization) 0.9% C (Modification) 0.8% C (Adverse Drug Reaction) 0.5% C (Authorization) 0.5% C (Prohibition) 0.4% C (Notification) 0.4%

20 Inspection Findings (cont d) Inspection Program Review ( ) Section of the Regulations (Description) % C (c) (Systems & Procedures) 38.1% C (h) (Informed Consent) 16.3% C (b) (Protocol Deviations) 15.2% C (j) (GMP) 9.2% C (g) (Qualification) 9.0% C (f) (Medical Decision) 3.8% C (d) (REB Approval) 1.9% C (a) (Protocol) 1.8% C (e) (# of QI per site) 0.9%

21 Inspection Findings (cont d) Common deficiencies observed under C (c): There was no written procedure on or the procedure did not adequately address (e.g., informed consent process, record retention, AE reporting, handling of the drug); No monitoring had been conducted to date at ; At the time of the inspection there was no documentation available to demonstrate that had been validated (e.g., electronic trial data system).

22 Inspection Findings (cont d) Examples of deficiencies observed C (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; Changes to the Protocol were not reported to Health Canada within 15 days. Changes to the protocol dated February 18, 2008 were reported to Health Canada on March 10, 2008

23 Inspection Findings (cont d) Examples of deficiencies observed C (c) Systems and procedures that assure the quality of every aspect of the clinical trial are implemented; There was no on-site monitoring at this site by the Sponsor, before, during and after the conduct of the clinical trial

24 Inspection Findings (cont d) Examples of deficiencies observed C (c) Systems and procedures that assure the quality of every aspect of the clinical trial are implemented; there was no maintenance/calibration program in place for the equipment used in the clinical trial (centrifuge and ECG apparatus); there was no procedure on how to obtain the informed consent from the patient; no procedure on when, where and how to archive research files; there was no procedure to explain what to do in case of power failure for the drug storage,

25 Inspection Findings (cont d) Examples of deficiencies observed C (1) Records There was no procedure or documentation available to demonstrate what study records would be maintained by the site, what personnel were authorized to access the records, measures to assure that records are kept in a secure location which maintains their integrity and confidentiality, and that records would be kept for 25 years.

26 Going Forward Developments within the GCP Program: Guide-0043 Classification of observations made in the conduct of inspections of clinical trials was posted on August 29, GCP pre-inspection package was developed which includes: Frequently Asked Questions Checklists Feedback Form The following vanity url was created: The Inspection Strategy is under review. Updated Summary Report of inspection findings.

27 QUESTIONS? Further information available online at: Health Canada Drugs and Health Products Compliance and Enforcement Good Clinical Practices

28 Coordonnées Candice Hilder Good Clinical Practices Compliance Unit Compliance, Enforcement, and Coordination Division Tel: (613) Generic

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