sponsors responcibilities

7/27/2019 Sponsors Responcibilities

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SPONSORS RESPONSIBILITIES

Dr Farheen Shaikh

Wockhardt Limited

Sponsor

Sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. An investigator is also sponsorif he takes all the responsibilitiesof a clinical trial.
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Sponsor team

Sponsor team contain following:

Project Manager

CRA/Monitor CRO (Contract Research Organization) Data Manager

Biostatician

Medical Writer

Responsibilities of sponsor


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1. Selection of Site and Investigator

Sponsor responsibility is to

select well qualified, trained andexperiencedinvestigator(s) for theconduct of trial. The selected

investigator should be based at theinstitutions/hospitals havingsufficient resources to properlyconduct the trial.


2. Allocation of Duties and ResponsibilitiesPrior to initiating a Study the


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Sponsor should define and allocateall Study related

duties and responsibilities to therespective identified

person(s)/organization(s).


3. Contract Research Organizati

on (CRO)A sponsor may transfer any or all ofthe sponsor's trial-relatedduties and functions to a CRO, butthe ultimate responsibility for thequality and integrity of the trial dataalways resides with the sponsor.


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The CRO should implement qualityassurance and quality control.


Any trial-related duty and function that is transferred to and assumed by a C

RO should be specified in writing. Any trial-related duties and functions not specifically transferred to and assumed bya CRO are retained by thesponsor. All references to a sponsor in this guideline also apply to a CRO to


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the extent that aCRO has assumed the trial related duties and funct

ions of a sponsor.


4. Medical ExpertiseThe sponsor shoulddesignate appropriately qualified

medical personnel who will bereadily available to advise on trialrelated medical questions orproblems.

If necessary, outside consultant's

may be appointed for this purpose.


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Responsibilities of spon

sor

5. Trial DesignThe sponsor should utilize qualified

individuals (e.g. biostatisticians,clinical pharmacologists, andphysicians) as appropriate,throughout all stages of the trial

process, from designing the protocoland CRFs and planning the analysesto analyzing and preparing interimand final clinical trial reports.



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6. FinancingThe financial aspects of the trial

should be documented in anagreement between the sponsorand the investigator/institution.


7. Notification/Submission to Re

gulatory Authority(ies)Before initiating the clinical trial(s),the sponsor (or the sponsor and theinvestigator, if required by theapplicable regulatoryrequirement(s)) should submit anyrequired application(s) to theappropriate authority(ies) (DCGI)


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for review, acceptance, and/orpermission (as required by the

applicable regulatoryrequirement(s)) to begin the trial(s).


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Any notification/submission should be dated and contain sufficient information to identify the protocol.


sor


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8. Confirmation of review by IRB/IEC

The particulars about themembers of the Investigators/Institutions Ethics Committeeincluding their names, addresses,

qualifications and experience.An undertaking that the Ethics

Committee is organized andoperates according to the GCP andthe applicable laws and regulations.


Documented approval / favorableopinion of the Ethics Committeebefore the initiation of the Study.


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The sponsor should obtain fromthe investigator/institution

documentation and dates of anyIRB/IEC reapprovals/re-evaluations with favorable opinion,and of any withdrawals or

suspensions of approval/favorableopinion.


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9.Trial Management, Data Hand

ling, and Record Keeping

The sponsor should utilizeappropriately qualified individuals tosupervise the overall conduct of the


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trial, to handle the data, to verifythe data, to conduct the statistical

analyses, and to prepare the trialreports.


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The sponsor may consider establishing an independent data-monitoring committee(IDMC) to assess the progress of a clinical trial, including the safety data and thecritical efficacy endpoints at intervals, and to recommend to the sp

onsor whether tocontinue, modify, or stop a trial.


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The IDMC should have writtenoperating procedures and maintai

n written recordsof all its meetings.


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When using electronic trial datahandling and/or remote electronic trial data systems, the sponsor should:

Maintain a security system thatprevents unauthorized access to the data. Maintain a list of the individualswho are authorized to make datachanges


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


10.Adverse Drug Reaction ReportingThe sponsor is responsible for


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reporting all adverse drug reactions(ADRs) that are both serious and

unexpected to all investigators,IRB/IEC involved in the particulartrial and to the regulatory authority(ies).

The Sponsor should provide ADR/AEreporting forms to theInvestigator(s)/Institution(s).


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11. Information on Investigational Product(s)When planning trials, the sponsorshould ensure that sufficient safetyand efficacy data from nonclinical


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studies and/or clinical trials areavailable to support human

exposure by the route, at thedosages, for the duration, and inthe trial population to be studied.


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11. Information on Investigatio

nal Product(s)The sponsor should update the

Investigator's Brochure assignificant new information becomes

available.



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12. Manufacturing, Packaging,

Labeling, and Coding Investigational Product(s)The sponsor should ensure that theinvestigational product(s) (including

active comparator(s) and placebo, ifapplicable) is characterized asappropriate to the stage ofdevelopment of the product(s),

is manufactured in accordancewith any applicable GMP, and



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is coded and labeled in a manner that protects the blinding, if ap

plicable. In addition, the labeling shouldcomply with applicable regulatoryrequirement(s).

The sponsor should determine, for the investigational product(s),

acceptable storage temperatures, storage conditions (e.g. protecti

on from light), storage times,


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The investigational product(s) should be packaged to prevent con

tamination andunacceptable deterioration during transport and storage.


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In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification oftheproduct(s) in case of a medicalemergency, but does not permit

undetectablebreaks of the blinding.


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13. Supply storage and handling of investigational product

The Sponsor is responsible for supplying the Investigational Products, includingComparator(s) and Placebo if applicable.


The sponsor should not supplyan investigator/institution with theinvestigational product(s) until th


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e sponsor obtains all required documentation (e.g. approval/favoura

ble opinion from IRB/IEC and regulatory authority(ies).

Sponsor should also maintain records of the quantities of Investig

ational Productwith proper batchnumbers.


Ensure timely delivery of investigational product(s) to the investigator(s). Sponsor may take steps to ensure that the investigational product


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(s) are stable overthe period of use.


14. Safety InformationThe sponsor is responsible for theongoing safety evaluation of theinvestigational product(s).

The sponsor should promptly notifyall concerned investigator(s)/institution(s) and the regulatoryauthority(ies) of findings that couldaffect adversely the safety of

subjects, impact the conduct of thetrial, or alter the IRB/IEC's


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approval/favourable opinion tocontinue the trial.


15. Monitoringa) Monitoring of clinical trial is theresponsibility of sponsor. Thesponsor should determine the

appropriate extent and nature ofmonitoring.b) The sponsor is responsible forthe appointment of monitors/CRAwho will monitor the conduct of the

trial is in compliance with the GCP,and with the applicable regulatoryrequirement(s).


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16. AuditIt's the responsibility of the sponsor

to perform an audit at all trial sitefor the purpose of carrying out theaudit, the sponsor may appointindividuals qualified by training and

experience to conduct audits.


The Auditors should be independent of the parties involved in thestudy and their qualifications sho


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vailable to the Regulatory Authorities


17. In Case of NoncomplianceNoncompliance with the protocol,SOPs, GCP, and/or applicableregulatory requirement(s) by an

investigator/institution, or bymember(s) of the sponsor's staffshould lead to prompt action by thesponsor to secure compliance.



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18. Premature termination or suspension of studyIn case the sponsor chooses or isrequired to terminate prematurelyor suspend the study, then thesponsor should notify the

investigator(s), institution(s), theethics committee and the regulatoryauthorities accordingly thenotification should document thereason(s) for the termination orsuspension by the sponsor or by theinvestigator /institution.


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19. Multi-centre studiesFor multi-centre studies, the

sponsor should ensure that allinvestigators/institutions involved inthe trial in strict adherence with theprotocol and applicable GCP

guidelines.Since multicentre studies areconducted simultaneously byseveral investigators at differentinstitutions following the same

protocol, the sponsor should makespecial administrative arrangementsfor their conduct.



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The CRFs are designed to capture the required data at all multice

ntre trial sites. For those investigators who are collecting additionaldata, supplemental CRFs should also be provided that are designed t

o capture the additional data.


20. Clinical trial/Study reportsWhether the trial is completed orprematurely terminated, thesponsor should ensure that theclinical trial reports are preparedand provided to the regulatory


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agency(ies) as required by theapplicable regulatory

requirement(s).


The sponsor should also ensurethat 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.

sponsors responcibilities

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