Clinical trial study team

the clinical research team and their Roles & responsibility.

1. CLINICAL TRIAL STUDY TEAM Presented by: Manju Jakhar M.Pharm (Pharmacology) 2nd Semester

2. The Research team Need sufficient study staff to perform clinical research . Appropriate skill set and training. GCP (Good clinical practice ) standards. Follow protocol requirements. Role and responsibility of clinical trial personnel:-

3. INVESTIGATOR CLINIC RESEARCH COORDINATOR(CRC) SPONSOR CONTRACT RESEARCH ORGANIZATION (CRO). RESEARCH TEAM RESPONSIBILITY Appropriate skill set and training. GCP (Good Clinical Practice) standards. Follow protocol requirements. RESEARCH TEAM

4. A investigator is the person who holds the responsibility for execution of clincal research. The investigator leads the research at the research site . It is the prime responsibility of investigator to ensure that the study is conducted in accordance with protocol , GCP and relevant regulations, and rights, safety and well being of research subjects as well protected during the research. As a leader investigator deligates research related tasks to other research staff. But he or she must oversight each and every deligated task even after deligating the task to others. Investigator should should be well versed with: ICH-GCP guidelines Applicable regulatory requirements 1.INVESTIGATOR:-

5. Study protocol is scientifically sound and particular study has scientific and social value. All required approvals are taken before commencing research. Helps in site selection; investigator varifies that there are adequate resources such as time, funding, manpower, infrastructure etc. Maintaining oversight for overall study activities and tasks delegated to research staff and other invoved parties at site. Investigator ensure that informed consent process is done properly. All research participants are made well aware about all aspects of research including risks and benefits of research. Investigator needs to ensure that all participants are properly treated and they are happy during research period. If any changes in study protocol investigator needs to get approval for the change from ethics committee, research participants need to be informed about changes made in protocol. Roles & Responsiblities of investigator:-

6. Investigator needs to ensure that all research participants are adhering to give research related instruction such as site visits, taking medicine etc. Investigator ensure that all kinds of reporting (eg. adverse reaction reporting) are done in a defined timeline to concerned partners. Data and study records are stored, retained and protected in accordance with prescribed guidelines and relevant regulations. Ensures that handling of investigational product is properly done. Medical assessments, efficacy evaluation of investigational product and determining therapy relationship with adverse events etc. Investigator allows smooth inspection and audits they also ensure that quality and integrity of clinical data is mantained. Analyses of clinical data are done according to pre-planned protocol analysis plan and in accordance with accepted statistical principles At end of study all the reports are prepared with accurate data for further submission. Selection of investigator :- education, Training, Experience

7. Clinical research cordinator is also known as study cordinator. Playes virtal role in clinical research project. Study cordinator works under principle investigator and supports the management and cordinates in daily trial activites. CRC gets involve since inception of result and continous still the completion of the project. Number of CRC in trial depends on workload at trial site. CRC consider as heart of clinical trial. 2.CLINIC RESEARCH COORDINATOR (CRC):-

8. Research cordinator plays an integral role in conduct of research. They are responsible for developing implementing and coordinating trial procedure for successful management. They work in cordination with a principle investigator and various department to ensure that the research is conducted in ethical manner and in accordance with prescribed SOP guidelines and applicable regulatory regulation. They ensure the safety and protection of human subjects in clinical trial . They work very closely with the participants and they have to do lots of intraction with participants such as – Educating volunteers regarding trial, Administrating medication to patient, Collecting correct data from the patient etc. CRC must have knowledgeabout all aspects of clinical trial because they are involved in various activities of trial such as- participants screening informed consent process scheduling of participant visits etc. During site finalizaation they play an important role as communicator between the investigator and the sponsor or CRO. Roles & Responsiblities of CRC:-

9. CRC prepare budget for study and look into various collaborations with funding agencies. During clinical trial it is responsibility CRC to check all the lab reports and to ensure these reports are reviwed and signed by investigator. If any adverse event or serious adverse event has occurred at trial site, it is the responsibility of study cordinator to inform the sence with all the details to appropriate departments and committee with define time line. Before a clinical trial is closed at the site clinical research cordinators have to ensure that all documents are checked properly and updated, after varification of all documents by research associate .CRC will suport in proper occuring of the documentsat the site . Study cordinator are rsponsible for reporting outcomes to all stakeholders. CRCs are involved in conducting research and managing various roles of research project such as- Planing and management of the study Obtaining grants for clinical research Recruitment and screening of participants Monitoring trial procedures Maintaining proper documentation Ensuring safety and wellbeing of participants are maintained Taking care of training activites Maintaining compliance regulations guidelines and ethics etc.

10. Sponsor is one who take the responsibility to initiate, finance, manage clinical trial. The sponsor can be- an individual Pharmaceutical company Government agency Academic institution Private or other organisation. Sponsor do not conduct the trial but they ultimately responsible for the quality and integrity of the clinical trial. Thus they carry no. of responsibility in order to complete the trial successfully and obtaining meaningful outcome. 3.SPONSOR:-

11. The sponsor should ensure that all aspects of the trail are operationally feasible . They should look into risk aspects involved in trial. They need to makesure that enough preclinical data and other relevant data is available to start trial in human. Sponsor may transfer some any or all of sponsors trial related duties and function to CRO, however sponsor hold the responsibility of quality and integrity of a trial data. Sponsor need to invovled well trained experience individuals in a trial to perform all the trial activites (data management, site selection, data analysis,planning and designing of trial etc.) smoothly and successfully. For example- Physician Data manager Administrator Biostatistician Role & Responsiblities of Sponsor:-

12. Before intiating or during clinical trial sponsor need to ensure that all reviews are done and permission are granted by appropriate authorities for all trial activities. Keeping check on shipment, handling, storage, administration return and disposal of investigational product or other medicinal product or device used during trial. Sponsor should report all the new information arising during the trial to all the concerned parties such as – Ethics committee, Health authority etc. Sponsor need to ensure that protocol and any other amendments are being followed. It is the responsibility of sponsore to makesure that all research personnel are well trained according to required regulations and ICH-GCP guildlines.

13. according to ICH-GCP guidelines:- CRO is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of sponsor’s trial- related duties and function.” CRO can support sponsor companies right form preclinical development of new products till post marketing research activites. CRO are well equipped with various facilities and have experties for conducting research related activities. CRO is able to support all activites related to a product life cycle right from the project initiation up to post marketing surveillance activities. Survicies provided by CRO include- Project initiation Producr development Pre-clinical research Clinical research Regulatory submission Post marketing surveillance 4.CONTRACT RESEARCH ORGANIZATION (CRO):-

14. Duties of sponsor and CRO should be listed down in the beginning of the outsourcing process and both the parties must stick to the defined duties. All the involved personal should be well aware of their roles and responsibilities. CRO must abide by contract signed with the sponsor. CRO needs to ensure that all clinical trial activities are conducted in according to applicable regulations and guidelines. CRO should commicate the concerned matters to sponsor in a timely manner. They should do proper documentation for all the activities. Responsiblities of CRC:-