the clinical research team and their Roles & responsibility.

1. 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.

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

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

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.

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.

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.

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.

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

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

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.