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Role and Responsibilities of CRO/Sponsor

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Sponsor
Sponsor is an individual, company, institution,

or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Sponsor team contain following Project Manager CRA/Monitor CRO (Contract Research Organization) Data Manager Biostatician Medical Writer 5/1/12

Responsibilities of sponsor
Selection of Site and Investigator Sponsor responsibility is to select well qualified, trained and experienced investigator(s) for the conduct of trial. The selected investigator should be based at the institutions/hospitals having sufficient resources to properly conduct the trial. Allocation of Duties and Responsibilities Prior to initiating a Study the Sponsor should define and allocate all Study related duties and responsibilities to the respective identified 5/1/12 person(s)/organization(s).

What is a Contract Research Organization?

FDA Definition: A CRO is a person that assumes, as an independent contractor of the sponsor, one or more obligations of the sponsor, such as design of the protocol, selection of the research site(s), monitoring of investigators, evaluation of the study data, and/or preparation of materials to be filed with the FDA. See 21 CFR 312.3(b) No definition in the device regulations. ICH Definition: A CRO is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsors trial-related duties and functions. See
GCP 1.20

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Contract Research Organization (CRO)

A sponsor may transfer any or all of the

sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control. Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.

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Contract Research Organization (CRO)

Any trial-related duties and functions not

specifically transferred to and assumed by a CRO are retained by the sponsor. All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial related duties and functions of a sponsor.

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Medical Expertise
The sponsor should designate appropriately

qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant's may be appointed for this purpose.

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Trial Design
The sponsor should utilize qualified

individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.

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Financing
The financial aspects of the trial should be

documented in an agreement between the sponsor and the investigator/institution.

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Notification/Submissi on to Regulatory Authority(ies) Before initiating the clinical trial(s), the

sponsor (or the sponsor and the investigator, if required by the applicable regulatory requirement(s)) should submit any required application(s) to the appropriate authority(ies) (DCGI) for review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain sufficient information to identify the protocol.

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Confirmation of review by IRB/IEC

a) The particulars about the members of the

Investigators/ Institutions Ethics Committee including their names, addresses, qualifications and experience. b) An undertaking that the Ethics Committee is organized and operates according to the GCP and the applicable laws and regulations. c) Documented approval / favorable opinion of the Ethics Committee before the initiation of the Study.
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Confirmation of review by IRB/IEC

The sponsor should obtain from the

investigator/institution documentation and dates of any IRB/IEC reapprovals/reevaluations with favourable opinion, and of any withdrawals or suspensions of approval/favourable opinion.

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Trial Management, Data Handling, and Record Keeping The sponsor should utilize appropriately

qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports. The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating procedures and maintain written records of all its meetings.
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Trial Management, Data Handling, and Record Keeping the sponsor When using electronic trial data handling and/or remote electronic trial data systems,
should:
Maintain a security system that prevents

unauthorized access to the data.

Maintain a list of the individuals who are

authorized to make data changes

Maintain adequate backup of the data. Safeguard the blinding, if any (e.g. maintain the
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blinding during data entry and processing).

Adverse Drug Reaction Reporting

The sponsor is responsible for reporting all

adverse drug reactions (ADRs) that are both serious and unexpected to all investigators, IRB/IEC involved in the particular trial and to the regulatory authority (ies). The Sponsor should provide ADR/AE reporting forms to the Investigator(s)/Institution(s).

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Information on Investigational Product(s) When planning trials, the sponsor should

ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied. The sponsor should update the Investigator's Brochure as significant new information becomes available.

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Manufacturing, Packaging, Labeling, and Coding Investigational the The sponsor should ensure that investigational product(s) (including active comparator(s) and Product(s)placebo, if applicable) is
characterized as appropriate to the stage of development of the product(s), is
GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s). The sponsor should determine, for the investigational product(s),
acceptable storage temperatures, 5/1/12

manufactured in accordance with any applicable

Manufacturing, Packaging, Labelling, and Coding Investigational The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport Product(s) and storage.
In blinded trials, the coding system for the

investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.

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Supply storage and handling of investigational product The Sponsor is responsible for supplying the

Investigational Products, including Comparator(s) and Placebo if applicable. The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation (e.g. approval/favourable opinion from IRB/IEC and regulatory authority(ies).

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Supply storage and handling of investigationalofproduct Sponsor should also maintain records the quantities of

Investigational Product with proper batch numbers. Ensure timely delivery of investigational product(s) to the investigator(s). Sponsor may take steps to ensure that the investigational product(s) are stable over the period of use.

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Safety Information
The sponsor is responsible for the ongoing

safety evaluation of the investigational product(s). The sponsor should promptly notify all concerned investigator(s)/ institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable opinion to continue the trial.
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Monitoring
a) Monitoring of clinical trial is the

responsibility of sponsor. The sponsor should determine the appropriate extent and nature of monitoring. b) The sponsor is responsible for the appointment of monitors/CRA who will monitor the conduct of the trial is in compliance with the GCP, and with the applicable regulatory requirement(s).

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Audit
It's the responsibility of the sponsor to

perform an audit at all trial site for the purpose of carrying out the audit, the sponsor may appoint individuals qualified by training and experience to conduct audits. The Auditors should be independent of the parties involved in the study and their qualifications should be documented. The purpose of a sponsor's audit is to evaluate trial conduct and compliance with the protocol, SOP, GCP, and the applicable regulatory requirements.
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Audit
The Sponsor should ensure that the auditing

is conducted in accordance with the Sponsors SOPs on what to audit, how to audit, the frequency of audit. Auditors should document their observations which should be archived by the Sponsors and made available to the Regulatory Authorities

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In Case of Noncompliance

Noncompliance with the protocol, SOPs, GCP,

and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance.

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Premature termination or suspension of study

In case the sponsor chooses or is required to

terminate prematurely or suspend the study, then the sponsor should notify the investigator(s), institution(s), the ethics committee and the regulatory authorities accordingly the notification should document the reason(s) for the termination or suspension by the sponsor or by the investigator /institution.

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Multi-centre studies
For multi-centre studies, the sponsor should

ensure that all investigators/institutions involved in the trial in strict adherence with the protocol and applicable GCP guidelines. Since multicentre studies are conducted simultaneously by several investigators at different institutions following the same protocol, the sponsor should make special administrative arrangements for their conduct.
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Multi-centre studies
The CRFs are designed to capture the required

data at all multicentre trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data.

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Clinical trial/Study reports

Whether the trial is completed or prematurely

terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline & Schedule Y (appendix II) for Structure and Content of Clinical Study Reports.
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CROs v SMOs
Sponsor

Sponsors Agent (CRO) Researcher 's Agent (SMO) Research Site/

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Investigat or

Potential Advantages of CROs

Reduce: Time needed to develop and commercialize a new product Sponsors fixed costs associated with personnel, equipment and facilities needed for its R&D function Provide: Ready access to needed expertise and/or technology Greater access to potential investigators Knowledge of regulatory climate in foreign markets

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Potential Risks of Outsourcing to CROs

Risks generally associated with reduced control

of the clinical trial process by the Sponsor Risks include: o Delays in completion of studies o Lost or poor data o Regulatory infractions produce indirect consequences

FDA regulations/GCPs HIPAA Fraud and Abuse o Private litigation exposure

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 Thank You

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