Web: www.crc.gov.my

Sponsor’s Responsibilities

Overview of Sponsor’s Responsibilities

5.0 Quality Management

5.1 Quality Assurance and Quality Control

5.2 Contract Research Organization (CRO)

5.3 Medical Expertise

5.4 Trial Designs

5.5 Trial Management, Data Handling and Record Keeping

5.6 Investigator Selection

5.7 Allocation of Duties and Functions

5.8 Compensation to Subjects and Investigators

5.9 Financing

5.10 Notification/ Submission to Regulatory Authority (ies)

5.11 Confirmation of Review by IRB/ IEC

5.12 Information on Investigational Product (IP)

5.13 Manufacturing, Packaging, Labeling and Coding IP

5.14 Supplying and Handling IP

5.15 Record Access

5.16 Safety Information

5.17 Adverse Drug Reaction Reporting

5.18 Monitoring

5.18.1 Purpose

5.18.2 Selection and Qualifications of Monitors

5.18.3 Extent and Nature of Monitoring

5.18.4 Monitor’s Responsibilities

5.18.5 Monitoring Procedures

5.18.6 Monitoring Report

5.18.7 Monitoring Plan

5.19 Audit

5.19.1 Purpose

5.19.2 Selection and Qualifications of Auditors

5.19.3 Auditing Procedures

5.20 Non-compliance

5.20.1 Management of non-compliance issues

5.21 Premature Termination or Suspension of a Trial

5.22 Clinical Trial/ Study Reports

5.23 Multicentre Trials

Four Key Priorities

Quality Management

Trial Management, Data Handling and

Record Keeping

Supplying and Handling of IP

Monitoring

Quality Management

5.0.1 Critical Process and Data Identification

5.0.2 Risk Identification

5.0.3 Risk Evaluation

5.0.4 Risk Control

5.0.5 Risk Communication

5.0.6 Risk Review

5.0.7 Risk Reporting

5.0 Quality Management

The sponsor should implement a system to manage

quality throughout all stages of the trial process.

Focus on ensuring human subject protection and

reliability of trial results.

Ensure operationally feasible, and should avoid

unnecessary procedures.

Ensure operational documents e.g. protocol and case

report forms (CRF) are clear, concise and consistent.

For example,

5.0.1 Critical Process and Data Identification

For example,

5.0.2 Risk Identification

For example,

5.0.3 Risk Evaluation

For example,

5.0.4 Risk Control

For example,

5.0.5 Risk Communication

For example,

5.0.6 Risk Review

For example,

5.0.7 Risk Reporting

For example,

5.5 Trial Management, Data Handling and Record

Keeping

The sponsor should utilize appropriately qualified

individuals.

The sponsor may consider establishing an independent

data-monitoring committee (IDMC).

Embracing the electronic trial data handling.

Ensure electronic data processing systems conform to the

sponsor’s established requirements for completeness,

accuracy, reliability and consistent intended performance.

Maintain SOPs for the use of these systems.

Ensure availability of audit trail for electronic data

capture (EDC).

Maintain a security system.

Maintain a list of individuals who are authorized to

access to the data.

Maintain adequate back-up of data.

Safeguard the blinding.

Ensure data integrity.

Use an unambiguous subject identification code.

Retain all of the sponsor-specific essential documents

pertaining to the trial.

If the trial is discontinued, should maintain all sponsor-

specific essential documents for at least 2 years.

After completion of the trial, the essential documents

should be retained for at least 2 years after the last

approval of a marketing application in ICH region.

5.14 Supplying and Handling of IP

The sponsor is responsible for supplying the IP to the

investigators/ institutions.

Note: The IP accountability is the responsibility of the

investigator

Should not supply an investigator/ institution with the IP

until the sponsor obtains all required documentations.

Ensure that there are written procedures for

investigators/ institutions from receipt to disposal/ return

of the IPs.

Ensure timely delivery of IP, maintain records, maintain

IP retrieval and unused IP disposition system, IPs are

stable and maintain sufficient quantity of IP.

5.18 Monitoring

The purpose of the trial monitoring.

The selection on the qualifications of monitors.

The extent and nature of monitoring:

Ensure trials are adequately monitored.

Develop a systematic, prioritized, risk-based approach to

monitoring clinical trials.

On-site monitoring vs. centralized monitoring.

Review of accumulating data from centralized monitoring.

Monitor’s Responsibilities:

Ensure that the trial is conducted and documented properly.

Main line of communication between the sponsor and

investigator.

Verify that the investigator has adequate qualifications and

resources.

Verify IP handling and use at the clinical trial site.

Verify that the investigators adhered to the clinical trial

conduct.

Checking the accuracy and completeness of the CRF

entries, source documents and trial related records.

Ensure all AEs are reported at timely manners.

Ensure handling of clinical trial deviations.

Monitoring Report

Monitoring Plan

5.1 Quality Assurance and Quality Control

QA vs. QC

5.2 Contract Research Organization (CRO)

Differences between CRO and sponsor.

5.4 Trial Design

Qualified individuals to manage all stages of trial

process.

5.6 Investigator Selection

Criteria of selection.

Sponsor providing investigator and institution the

updated protocol and IB.

Obtain agreement from investigator/ institution for the

conduct of the study.

5.8 Compensation to Subjects and Investigators

Provide insurance and indemnification to the

investigator/ institution against claims arising from the

trial.

Address the costs of treatment of trial subjects in the

event of trial-related injuries.

5.9 Financing

Should be documented in an agreement between

sponsor and investigator/ institution.

5.10 Notification/ Submission to Regulatory

Authority (ies)

Responsibilities of the sponsor to obtain all of the

documents required by the regulatory authority (RA)

for the clinical trial.

5.1.1 Confirmation of Review by IRB/ IEC

Should ensure the investigator/ institution obtain the

required approval from IRB/ IEC.

5.12 Information on IPs

Reference: covered in the IB topic

5.13 Manufacturing, Packaging, Labeling and

Coding IPs

Ensure the IP is manufactured, stored, coded and

packaged according to the GCP.

5.15 Record Access

Ensure that the investigator/ institution provide direct

access to source data/ documents.

5.16 Safety Information

Responsible for the ongoing safety evaluation of the

IPs.

Inform all relevant concerned investigators/

institutions/ RA of the findings.

5.17 Adverse Drug Reaction (ADR) Reporting

Should expedite reporting to all concerned parties of

all ADRs that are both serious and unexpected.

Reference: ICH Guideline for Clinical Safety Data

Management.

5.19 Audit

Independent/ separate from routine QC function.

To evaluate trial conduct and compliance to SOP, GCP and

required applicable regulatory requirements.

5.20 Noncompliance

Should lead to prompt action by the sponsors to secure

compliance.

Should perform root cause analysis and implement

CAPA.

For serious noncompliance, sponsor should terminate

investigator/ site participation.

5.21 Premature Termination or Suspension of a

Trial

Inform the investigator/ institution and RA of the

termination/ suspension and its reasons.

5.22 Clinical Trial/ Study Reports

Prepare clinical trial study reports and provide to RA if

the trial is completed or prematurely terminated.

5.23 Multicentre Trials

Ensure that all investigators conduct the trial in strict

compliance to the protocol.

The CRFs are designed to capture the required data.

The responsibilities of coordinating investigators and

participating investigators are documented prior to the

start of the trial.

All investigators are given uniform instructions on

following the protocol.