2. 2
Investigator Qualification
ICH – GCP: (4.1.1)
The investigator(s) should be qualified by
education, training, experience to assume
responsibility for the proper conduct of the trial,
should meet all the qualifications specified by the
applicable regulatory requirement(s)
Indian GCP: (3.3.1)
The investigator should be qualified by education,
training and experience to assume responsibility
for the proper conduct of the study and should
have qualifications prescribed by the Medical
Council of India (MCI).
3. 3
Investigator and sponsor’s
SOPs
ICH – GCP:
Investigator to comply with the protocol (4.5)
and leaves the task of monitoring compliance
to SOPs to monitors and auditors (5.19.1).
Indian GCP: (3.1.3)
The Sponsor should establish detailed
Standard Operating Procedures (SOP’s). The
Sponsor and the Investigator(s) should sign a
copy of the Protocol and the SOPs or an
alternative document to confirm their
agreement.
4. 4
Investigators responsibility for data
analysis
ICH – GCP: (4.10)
when the trial is completed, the investigator has
to provide the Independent Ethics Committee
(IEC) with a summary of the outcome of trial.
Indian GCP: (3.3.8)
The completion of the study should be informed
by the investigator to the institution, the sponsor
and the ethics committee. The investigator should
sign and forward the data (CRFs, results and
interpretations, analyses and reports, of the study
from his / her centre to the sponsor and the ethics
committee.
5. 5
Essential Documents
ICH – GCP: (8.2)
Investigator/ Sponsor
Institution
Indian GCP: (APPENDIX V)
Investigator / Institute
Sponsor
CRO
IEC
6. 6
Monitor Responsibilities
ICH – GCP: (5.18.4)
Communicating deviations from the protocol, SOPs,
GCP, and the applicable regulatory requirements to
the investigator and taking appropriate action
designed to prevent recurrence of the detected
deviations.
Indian GCP: (3.2.2)
The monitor should promptly inform the sponsor and
the ethics committee in case any unwarranted
deviation from the protocol or any transgression of
the principles embodied in GCP is noted.
7. 7
Drug Label
Indian GCP: (2.3.1.6)
In the section on protocol, it is mentioned that
drug label should include name and contact
numbers of investigator and name of institution.
This is not a global practice.
This will lead to practical difficulties in global
trials where the labels are uniform with minor
changes made if required by local laws and
practice.
8. 8
Document Retention
ICH – GCP: (5.18.4)
Essential documents should be retained until at
least 2 years after the approval of a marketing
application in an ICH region.
Indian GCP: (4.9)
Indian GCP mandates that the sponsor should make
arrangements for safe and secure custody of all
study related documents and material for a period
of three years after the completion of the study or
submission of the data to the regulatory authority
(ies) whichever is later.
