ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptx

describe about role of sponsor and CRO on clinical trial process

1. Roles And Responsibilities Of Sponsor And Contract Research Organization Praveen kumar.S M.Pharm 2 nd semester Department of pharmacology Psg college of pharmacy.

2. ICH -GCP Is an international conference on harmonization for good clinical practice. GCP is an international ethical and scientific quality standard for designing , conducting,recording and reporting trials that involve the participation of human subjects . Sponsor In conduct of clinical trial ,a sponsor is an individual ,company ,institution , or organization that takes responsibility for the initiation ,management and financing of clinical trial. sponsor includes commercial pharmaceutical and device companies ,government funding agencies ,private foundations and individuals.

3. Sponsor team : Project manager CRA/MONITOR CRO Data manager Biostatician Medical writer.

4. Clinical trial study sponsor responsibility: Specific regional requirement for a clinical study sponsor can vary , generaly sponsor is responsible for, Selecting the investigators. Providing investigators with the necessary information to conduct the clinical trial. Ensure proper monitoring of the clinical study . Ensuring all the necessary ethic reviews and approval are obtained. Preparing and submitting clinical trial application and amendment to the appropriate regulatory agencies .

5. Cont .. Ensuring that any reviewing ethics board and regulatory agencies are promptly informed of any significant new information. (for eg:important findings that affect product safety in a clinical study. Ensuring compliance with labelling ,reporting and record keeping requirements . Refraining from engaging in promotional activities and other prohibited activities such as commercially an investigational medical device . Ensuring clinical safety is conducted in accordance with good clinical practice (GCP).

6. Trial design The sponsor should utilize qualified individuals ( eg . Biostaticians ,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 the interim and final clinical trial reports. A description of the trial design ,should include : Primary and secondary endpoints ,description of the type /design of trial to conducted and its measures ,trial treatment and dosage ,stopping rules or discontinuation criteria for individual subjects ,accountability ,etc…

7. Trial management ,data handling and record keeping: The sponsor should consider in establishing an IDMC by utilizing qualified individuals to assess the progress of a clinical trial . When using electronic trial data handling or remote electronic trial data system ,the sponsor should: Maintain SOPs for using these system , Any transfer of ownership of the data should be reported to the appropriate authorities. The sponsor specific essential documents should be retained until atleast 2 years after the last approval of a marketing application. The sponsor should inform the investigators /institution in writing of the need for record retention and should notify accordingly.

8. Investigator selection: The sponsor is responsible for selecting the investigator . The sponsor should provide the investigator with the protocol and an up to date investigators brochure . The sponsor should obtain the investigator’s agreement: To conduct the trial in compliance with GCP. To comply with procedures for data recording, To permit monitoring ,auditing and inspection. The sponsor and investigator /institution should sign the protocol ,or alternative document ,to confirm this agreement.

9. Allocation of responsibilities : prior to initiating a trial, the sponsor should define ,establish and allocate all trial –related duties and functions. Compensation to subjects and investigators: The sponsor should provide insurance or should indemnify the investigator against claims arising from the trial ,except for claims that arise from malpractice . The sponsors policies and procedures should address the cost of treatment of trial subjects in the event of trial related injuries in accordance with applicable regulatory requirements. when trial subjects receive compensation ,the method and manner of compensation should comply with applicable regulatory requirements.

10. Financing : The financial aspects of the trial should be documented in an aggrement between the sponsor and the investigator /institution. Confirmation of review by IRB/IEC : The sponsor should obtain from the PI/institution regarding : The name and address of the Pis /institution’s IRB/IEC. A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations Document IRB/IEC conditions its approvable / favourable opinion. If the IRB/IEC conditions its approval /favorable opinion upon changes in any aspect of the trial.

11. Information on investigational products When planning trials ,the sponsor should ensure that sufficient safety and efficacy data from non clinical studies 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 investigators brochure as significant new information becomes available .

12. Manufacturing ,packaging ,labelling and coding investigational products: The sponsor should determine for the investigational products ,acceptable storage temperature ,storage condition and storage duration reconstitution fluid times and procedures ,device for product infusion The investigational product should be packaged to prevent contamination and unacceptable detoritation during transport and storage. In blinded trials the coding system for the investigational products should include a mechanism that permits rapid identification of the products in case of medical emergency.

13. Supplying and handling investigational product: The sponsor is responsible for supplying the investigators with the investigational prducts . The sponsor should , Ensure timely delivery of investigational product to the investigators . Take steps to ensure that the investigational products are stable over the period of use. Maintain a system for the disposition of unused investigation product and for the documentation of this disposition.

14. Record access: The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator provide direct access to source data /documents for trial related monitoring ,audits ,IRB /IEC review and regulatory inspection. The sponsor should verify that each subject has consented ,in writing ,to direct access to his /her original medical records for trial related monitoring .

15. Adverse drug reaction reporting : The sponsor should expedite the reporting to all concerned investigators to the IRB/IEC where required and to regulatory authorities of all adverse drug reactions (ADRs)that are both serious and unexpected.

16. Premature Termination or Suspension of a Trial: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority (ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).

17. Multicentre Trials: The sponsor should ensure that: All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority, and given approval/favourable opinion by the IRB/IEC. 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. The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial. All investigators are given instructions on the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings. Communicationn between investigators is facilitated.

18. Contract research organization A contract research organization is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.

19. A CRO is thoroughly skilled in handling complex drug development programs demanding new regulatory and clinical approaches and will have know-how in implementing and realizing successful completion of novel drug development endeavors. CONTRACT RESEARCH Legal Background •The arrangements made for the conduct of clinical research willusually give rise to a number of legal contracts. • For example, there will be a contract between a sponsor and any appointed clinical research organization (CRO); between the sponsor or CRO and the investigator or the institution in which the investigator works.

20. A list of qualified CROS is developed based on:- The sponsors needsThe range of services provided by CRO The therapeutic area of expertise of CRO, and- The compatibility with the sponsor WHEN TO USE A CRO? Strategies for using CROS typically fall into three categories:- Tactical outsourcing- Maximal outsourcing- Strategic outsourcing Tactical OutsourcingIndividual studies or selected activities within a study are contracted to a CRO only when in-house resources become inadequate because of an unfore-seen study or a reduction in staff. Maximum OutsourcingWith this strategy the sponsor outsources nearly all of its clinical development activities to CROS. Strategic Outsourcing• The sponsor conducts Phase I and early Phase II studies, and hires CROS to conduct larger and routine studies.

21. THREE CRITICAL STEPS TOENSURE SUCCESS WITH A CRO • In order to ensure successful outsourcing, the sponsor should focuson three critical steps:...- Determine accurate study specifications - Select the right CRO- Manage the study

22. DETERMINE STUDY SPECIFICATIONS. . . Study specifications are a list of activities required to initiate, conduct, analyze, and report the results of a clinical study. They include tasks that will be performed in-house and those to becontracted out to one or more CROS. Importance of Accurate Study SpecificationsStudy specifications are an essential element of the sponsor's request for proposal (RFP) and the CRO's proposal. Accurate study specifications also enable the CRO to perform a 'reality check' on the sponsor's expectations. This analysis also provides useful criteria for selecting the right CRO.

23. SELECTING THE RIGHT CRO The three most important criteria for selecting a CRO are:- Capability - Compatibility - Cost MANAGING THE SPONSOR-CRO RELATIONSHIP The sponsor should follow three principles for managing an outsources project:- Clarify the role and responsibilities of the sponsor and CRO. Define and use performance metrics' to measure study progress. Ensure efficient communication between the sponsor and CRO.

24. Responsibility of CRO Implementation of systems and procedures for the conduct of clinical trials andassessment of the safety in carrying out those trials. 2. Taking complete responsibility to ensure that the CTs are conducted in accordance with the guidelines and regulations, whether they are specified by the pharmaceutical industry or by the companies they are carrying out the research for. 3. Following the terms of the research contract it has signed with the sponsor. 4. Communicating concerns associated with the trials to the sponsors on a regular and timely basis. These concerns include the progress in the trial, complications, risks and more 5. Assuring to maintain quality and metrics throughout the procedure in order to getthe accurate and unbiased results. 6. Last but not least responsibility of a CRO is to record the trial results andmaintain accuracy in all those records.

25. Study details The protocol should be incorporated by reference into thecontractThe protocol must not be deviated from, except: 1. As agreed in writing between the parties and approved by theethics committee. 2. In the opinion of the investigator, it is necessary to do so immediately in order to protect the health and safety of aresearch subject. A key person' clause should be considered. This might specify that identified individuals, or a certain number of staff specified minimum qualifications, will work on the study. The contract should address whether the CRO or investigator isallowed to subcontract any of their obligations and, if so, whichof them.

26. Compliance • A specified party must hold or obtain (and maintain) all necessary authorizations. • All legal and regulatory requirements (including labeling) must be Compliance with the ICH. Good Clinical Practice Guidelines or equivalent should be required. The investigator must obtain ethical approval from relevant ethics committees before beginning the study and refer all amendments. The study must be carried out to the highest professional standards.

27. Data Except for the purposes of the study and as required by law, thedata must be kept confidential.Retention of title by specified parties (in particular the sponsor) in identified documents and materials should spelled out. • Protection of intellectual property rights of the sponsor must becovered. • Arrangements for maintaining safety and security of data,documents and trial supplies should be identified. • The investigator will maintain all records relating to the study, including case report forms, for as long as is practicable.Responsibility and procedure for notification of Adverse Drug Reactions (ADRs) or other unexpected or unusual occurrences in compliance with the legislation needs to be described.

28. Payment The contract should specify: The amounts and timing (advance, stage or interim and final) of payments and the payment of reasonable expenses. • Whether separate accounts are to be established.Provision for alteration of budget in the event of amendment of the protocol, or extent of services to be provided, and early termination. Materials • Supply of the investigator brochure, updates, product and documentation by sponsor.

29. CONCLUSION More effective contracting of clinical drug-development activities to CROS can be achieved by applying the following methods:- Use a strategic approach to outsourcingFollow the three principles for achieving success with CROS: define accurate study specifications; select the right CRO: andmanage the study. Select CROs according to the three Cs: capability, compatibilityand cost. Evaluate the CRO's resource allocationsDefine the performance metricsEnsure efficient communication with CRO

30. Thank you