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SPONSORS RESPONSIB ILITIES

Dr Farheen Shaikh Wockhardt Limited

Sponsor

Sponsor is an individual, compa ny, institution, or organization whi ch takes responsibility for the initi ation, management, and/or financ ing of a clinical trial. An investigator is also sponsor if he takes all the responsibilities of a clinical trial.

Sponsor team
Sponsor team contain following :
Project Manager CRA/Monitor CRO (Contract Research Org anization) Data Manager Biostatician Medical Writer

Responsibilities of spon sor

1. Selection of Site and Investi gator

Sponsor responsibility is to select well qualified, trained and experiencedinvestigator(s) for the conduct of trial. The selected investigator should be based at the institutions/hospitals having sufficient resources to properly conduct the trial.

Responsibilities of spon sor

2. Allocation of Duties and Resp onsibilities
Prior to initiating a Study the

Sponsor should define and allocate all Study related duties and responsibilities to the respective identified person(s)/organization(s).

Responsibilities of spon sor

3. Contract Research Organizati on (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.

Responsibilities of spon sor

Any trialrelated duty and function that is tr ansferred to and assumed by a C RO should be specified in writing. Any trialrelated duties and functions not s pecifically transferred to and assu med bya CRO are retained by the sponsor. All references to a sponsor in th is guideline also apply to a CRO to

Responsibilities of spon sor

4. Medical Expertise

the extent that aCRO has assume d the trial related duties and funct ions of a sponsor.

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.

Responsibilities of spon sor

5. 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.

Responsibilities of spon sor

6. Financing
The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.

Responsibilities of spon sor

7. Notification/Submission to Re gulatory 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)

Responsibilities of spon sor

for review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s).

Any notification/submission sho uld be dated and contain sufficien t information to identify the proto col.

Responsibilities of spon sor

8. Confirmation of review by I RB/IEC

The particulars about the members of the Investigators/ Institutions Ethics Committee including their names, addresses, qualifications and experience. An undertaking that the Ethics Committee is organized and operates according to the GCP and the applicable laws and regulations.

Responsibilities of spon sor

Documented approval / favorable opinion of the Ethics Committee before the initiation of the Study.

The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC reapprovals/reevaluations with favorable opinion, and of any withdrawals or suspensions of approval/favorable opinion.

Responsibilities of spon sor

9.Trial Management, Data Hand ling, and Record Keeping
The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the

Responsibilities of spon sor

The sponsor may consider esta blishing an independent datamonitoring committee(IDMC) to a ssess the progress of a clinical tria l, including the safety data and th ecritical efficacy endpoints at inter vals, and to recommend to the sp onsor whether tocontinue, modify , or stop a trial.

trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.

Responsibilities of spon sor

The IDMC should have written operating procedures and maintai n written recordsof all its meeting s.

When using electronic trial data handling and/or remote electroni c trial data systems, the sponsor s hould: Maintain a security system that prevents unauthorized access to t he data. Maintain a list of the individuals who are authorized to make data changes

Responsibilities of spon sor

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

Responsibilities of spon sor

10.Adverse Drug Reaction Repo rting

The sponsor is responsible for

Responsibilities of spon sor

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).

11. Information on Investigatio nal Product(s)

When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical

Responsibilities of spon sor

11. Information on Investigatio nal Product(s)
The sponsor should update the Investigator's Brochure as significant new information becomes available.

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.

Responsibilities of spon sor

12. Manufacturing, Packaging, Labeling, and Coding Investiga tional Product(s)

The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and

Responsibilities of spon sor

Responsibilities of spon sor

is coded and labeled in a mann er that protects the blinding, if ap plicable. In addition, the labeling should comply with applicable regulatory requirement(s). The sponsor should determine, fo r the investigational product(s), acceptable storage temperature s, storage conditions (e.g. protecti on from light), storage times,

Responsibilities of spon sor

The investigational product(s) s hould be packaged to prevent con tamination andunacceptable deter ioration during transport and stor age.

In blinded trials, the coding sys tem for the investigational produc t(s) should include a mechanism t hat permits rapid identification of theproduct(s) in case of a medical emergency, but does not permit undetectablebreaks of the blindin g.

Responsibilities of spon sor

13. Supply storage and handlin g of investigational product
The Sponsor is responsible for s upplying the Investigational Produ cts, includingComparator(s) and P lacebo if applicable.

Responsibilities of spon sor

The sponsor should not supply an investigator/institution with the investigational product(s) until th

Responsibilities of spon sor

e sponsor obtains all required doc umentation (e.g. approval/favoura ble opinion from IRB/IEC and reg ulatory authority(ies). Sponsor should also maintain re cords of the quantities of Investig ational Productwith proper batch numbers.

Ensure timely delivery of investi gational product(s) to the investig ator(s). Sponsor may take steps to ensu re that the investigational product

Responsibilities of spon sor

14. Safety Information

(s) are stable overthe period of us e.

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

Responsibilities of spon sor

15. 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).

approval/favourable opinion to continue the trial.

Responsibilities of spon sor

16. 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.

Responsibilities of spon sor

The Auditors should be indepen dent of the parties involved in the study and their qualifications sho

uld be documented. The purpose of a sponsor's audit is to evaluate trial conduct and compliance with the protocol, SOP, GCP, and the a pplicable regulatory requirements.

Responsibilities of spon sor

The Sponsor should ensure that the auditing is conducted in accor dance with the Sponsors SOPs on what to audit, how to audit, the f requency of audit. Auditors should document their observations which should be arc hived bythe Sponsors and made a

Responsibilities of spon sor

17. In Case of Noncompliance

vailable to the Regulatory Authorit ies

Responsibilities of spon sor

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.

18. Premature termination or s uspension 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.

Responsibilities of spon sor

19. 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.

Responsibilities of spon sor

The CRFs are designed to captu re the required data at all multice ntre trial sites. For those investiga tors who are collecting additional data, supplemental CRFs should al so be provided that are designed t o capture the additional data.

Responsibilities of spon sor

20. 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

Responsibilities of spon sor

The sponsor should also ensure that the clinical trial reports in m arketing applications meet the sta ndards of the ICH Guideline & Sch edule Y (appendix II) for Structur e and Content of Clinical Study Re ports.

agency(ies) as required by the applicable regulatory requirement(s).