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Roles & Responsibilities - CRA

Corporate Headquarters:

Max House, G.F.

1 Dr. Jha Marg, Okhla

New Delhi 110020

India

Dr. Aditi Parekh

1st 5th Dec. 2010

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Presentation Overview Monitoring

Purpose of Monitoring

Functions of Monitor

Monitoring Strategy

Monitoring Frequency

Pre Visit Activities Principles of CRF Retrieval

Good High Quality Data

Essential Documents Monitoring Visit Reports

Importance of Job

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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, Standard

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pera ng roce ures, an e app ca eregulatory requirements

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Clinical Trial Monitoring :Purpose

Verification of

o Protection of rights and well-being of trial subjects

o Accuracy, completeness of data confirmed with

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Conduct of trial as per

o Approved / amended valid protocol

o Good Clinical Practice

o Regulatory requirements

Conduct by authorised, trained personnel

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Functions of Monitor

Monitor progress and quality of trial conduct

Communication link between sponsor and

investigator

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ssess a equacy o s e ac es, resources Manage trial logistics, finance and archiving

Adequate / continuous training to investigator

and team

Support EC / IRB approvals and re-approvals

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Monitoring Strategy

What ?

o Facilities

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o Investigator fulfilling obligations

o Data quality

Where ?

o Each trial site

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Monitoring Strategy

When ?

o immediately after first 2 patients, then every

4-6 weeks

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Who ?

o monitors of sponsor, CRO, independent

How ?o telephone, fax, letters, emails, visits

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Monitoring Frequency

Depends on

Complexity of protocol

Disease under evaluation

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xper ence o nves ga or s a

Number of enrolled subjects

Rate of enrolment

Site performance Sponsor monitoring SOPs

CRA experience and effectiveness

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Monitoring : Pre-visit Activities

Plan in advance Inform site personnel

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- ,

Medication supplies

Outstanding issues

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Proper Planning Prevents Poor

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Monitoring Strategy

SAE review

ICF review

Checking protocol adherence

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CRF review and SDV

Queries and error correction

IP review and accountability Study document file review

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Monitoring Strategy SDV

Start with new subjects, those enrolled duringthe last visit

Next, review other currently enrolled subjects

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Check all CRFs for a patient before doing

source document review

Then do SDV before checking next patientsCRF

Finish one subject at a time

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8hrs@site.com

Exit @ site

Time to meet the investigator for your monitoring

findings Site file review

Drug accountability

Corrections to the CRFs/post its review Safety review

SDV and CRF retrieval

ICF review

Meeting with investigator / site team

Entry @ site 15

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Principles of CRF Retrieval

Never withdraw single pages

Alwa s focus on modules or at least er visit

schedules

Never focus on single visit withdrawals

1616 Feb 2008

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Good High Quality Data

Can be evaluated and analyzed Allow valid conclusions be made

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Do not need to be queried

Are consistent across subjects and sites

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Good High Quality Data

Subjects meet entry criteria All fields are complete

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Values are within range

Units for measurement are correct

There are no extraneous comments

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Essential Documents : DuringConduct of Clinical Trial

Updates & amendments of all items Monitoring visit reports

Relevant letters, meeting notes, telephones calls

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Signed informed consent forms

Source documents

Signed, dated & completed CRFs

Documentation of CRF corrections

Adverse event reporting

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Essential Documents : DuringConduct of Clinical Trial

Notification of safety information Interim or annual reports

Subject screening log

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Subject identification code list

Subject enrolment log

Investigational products accountability at site

Signature sheet of authorized persons

Record of stored lab samples

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Monitoring Visit Reports

Document findings from the visit

o Summary of visit

o Collected CRFs

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o Document problemso Action items for next visit

Business language

Report for each visit

Catch up on the missed activities during monitoring

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Why is your job important?

because You Are the companys primary protector of

research subjects rights and well being

Play a critical role in ensuring that datagenerated in clinical investigations arecredible and accurate

Are the key to the companys upholding itsregulatory and legal responsibilities

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Messenger

Organizer

Negotiator

Monitor

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Inspector Trainer

Observer Reporter

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QUESTIONS

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Thank ou

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