joint research & enterprise office training the team, the procedures, the monitor and the...

Joint Research & Enterprise Office TrainingJoint Research & Enterprise Office Training

The team, the procedures, the monitor

and the Sponsor

Lucy H H ParkerClinical Research Governance Manager


CI and PIsMonitorRegulatory Assurance ManagerStats.?RN/CTA/DM

Research PharmacyArchivistFinanceSupport DepartmentsIT - eCRF

The Team


Lots of meetings!

Site selection

Risk Assessment (26 point risk assessment)

Major issues identified and minimised

Monitoring plan – agreed with all parties even if external monitor

Standard RG processes – initiation, routine, close out

Safety reporting

How are the studies set up?


Sponsor


Sponsor

• Sponsor takes on overall responsibility for initiation, management and/or financing of study

• All clinical trials must have a designated sponsor– Must be named in the protocol

• Not necessarily the funder– Typically CI employer

• Can delegate responsibilities to investigators

Joint Research & Enterprise Office Training

• Quality Assurance (audits)• Quality Control (monitoring)• Contracts & Agreements• Medical Expertise• Trial Design• Trial Management, Data Handling, and

Record Keeping• Investigator Selection• Allocation of Responsibilities• Compensation to Subjects and

Investigators• Financing• Submission to Regulatory Authorities

• Confirmation of Review by REC• Information on IMP• Manufacturing, Packaging, Labelling, and

Coding of IMP• Supplying and Handling of IMP• Record Access• Safety Information• Safety Reporting• Non-compliance• Premature Termination or Suspension of

a Trial• Clinical Trial/Study Reports• Multi-centre Trials

ICH GCP Section 5


Sponsor Responsibilities


Quality Assurance (QA) versus Quality Control (QC)

• QC = Quality Control = monitoring

– Member of trial team

– Ongoing

• QA = Quality Assurance = auditing

– Independent

– Planned and systematic



Monitoring



What is monitoring?


“The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP,

and any regulatory requirements”

ICH GCP Section 5.18



Purpose of Monitoring?


• Protection of rights and wellbeing of human participants– Ensure consent in place for record access

• Trial data are accurate, complete and verifiable from source documents

• Conduct of trial is in compliance with the currently approved protocol, GCP, and all applicable regulatory requirements

ICH GCP Section 5.18.1



Qualities of a Good Monitor?

• Appropriately trained• Adequate scientific and/or clinical knowledge

– Documented with training logs and CVs• Thoroughly familiar with:

– IMP– Protocol– Consent form– Sponsor & trial SOPs– GCP

• Knowledge of local laws, regulations, customs & local language




Extent and Nature of monitoring

• Monitoring should be proportionate to:– Objective– Purpose– Design– Blinding– Size and complexity– Outcome measures– Risks




Types Of Monitoring (1)

• Coordinating centre / day-to-day monitoring– Data collected are consistent with protocol– CRFs are being completed by authorised staff– No key data is missing– Data appears to be valid – Review of recruitment rate, withdrawals and losses to f/up




• Central monitoring– Determination of key eligibility criteria through collection of:

• Consent forms (with agreement by participant)• Scans• Pathology reports

– Statistics• Unusual patterns of data




• On-site monitoring– Staff training– Access to necessary documents– Confirm pharmacy and lab resources in place

• Count study drugs– Adherence to protocol and GCP– Check medical records

• Consent forms• Eligibility• SAEs, SADRs, SUSARs etc

– Source Data Verification (SDV)



CRF Completion Data Entry

Data cleaning & Validation

Data entry checks

Double data entry

Post entry checks

Monitoring visits & SDV

Training Investigators

OCR

Data Management & Processing

EDC system



Common queries and checks


• Most common checks to identify discrepancies: – Missing values– Range checks, including lab values and normals– Logical date sequence– Header information consistent– Missing visits or pages– Visits in compliance with protocol– Inclusion/exclusion criteria met– Procedures performed in proper order– Fraud



Post1. Data manager cleans &

validates database

2. Problems such as missing values or inconsistencies

3.Queries addressed to the PI via paper query forms

4. PI resolves queries

5. Query resolutions put on query form

6. Monitor checks query resolutions

7. Query forms with resolution sent back to data manager

8. Corrections entered in database

Data validated

No

Yes


Post Entry Checks



MONITORING & AUDITS

Ensuring the Quality of the Data


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