Prior to selection of a clinical study site, the
sponsor/CRO must confirm and document, in the
pre-study assessment visit report, that the investi-
gator has access to a local ethics committee/IRB.
Local committees cannot be bypassed: the only
official exception to this requirement is France,
where, by regulation, a central committee may
rule for all sites in a multicenter study. However,
in the United States, it appears to be common
practice for a central IRB to rule for the widelyTable 12.3 Investigator GCP responsibilities
The following investigator responsibilities must be declared in agreements or contracts:
Adhere to the protocol exactly. No changes to the protocol may be undertaken without following a formal
protocol amendment procedure and without agreement by the sponsor/CRO
Be thoroughly familiar with the properties of the clinical study medications/devices as described
in the investigator brochure
Have sufficient time to personally conduct and complete the study. If more than one investigator is involved
at a specific study site, the specific responsibilities must be described for each investigator. The investigator must
ensure that no other studies divert study subjects, facilities or personnel from the study under consideration
Maintain the confidentiality of all information received with regard to the study and the investigational study
medication/device
Submit the protocol, information sheet and consent form, and other required documentation, to an
ethics committee/IRB for review and approval before the study begins. During the study, the investigator
is also responsible for submitting any new information, for example protocol amendments, safety information,
which might be important for continuing risk assessment by the ethics committee/IRB
Obtain informed consent from each study subject prior to enrolment into the study
Inform the subjects primary care physician, e.g. general practitioner or family physician, of proposed study
participation before enrolment into the study
Maintain study subject clinical notes, that is source documents, separately from the CRFs. The source documents
must support the data entered into CRFs and must clearly indicate participation in a clinical study. If the study
subject is referred by another physician, the investigator must ensure that sufficient evidence is available in the
clinical notes to support the eligibility of the study subject
Maintain a confidential list identifying the number/code and names of all subjects entered into the study
Allow authorized representatives of the sponsor/CRO and regulatory authorities direct access to study subject
clinical notes (source documents) in order to verify the data recorded on CRFs
Ensure CRFs are complete and accurate
Allow monitoring visits by the sponsor/CRO at a predetermined frequency. During these monitoring visits, the
monitor must be allowed to communicate with all site personnel involved in the conduct of the clinical study
Report all AEs and SAEs to the sponsor/CRO and follow the special reporting requirements for SAEs
Maintain the security and accountability of clinical study supplies, ensure that medications/devices are labeled prop-
erly, maintain records of clinical study medication/device dispensing, including dates, quantity and use by study
subjects; and return or disposition (as instructed by the sponsor/CRO) after completion or termination of the study
Archive all CRFs and documents associated with the study for a minimum of 15 years. Notify the sponsor/CRO of
any problems with archiving in potential unusual circumstances, for example investigator retires, relocates, dies;
study subject dies, relocates and so on
Provide reports of the study’s progress whenever required
Review the final clinical report, and sign and date the signature page after review
Allow an independent audit and/or inspection of all study documents and facilities
Agree to the publication policy
Agree to the sponsor’s/CRO’s ownership of the data
Agree to the stated time frames for the study, for example start and completion of recruitment, submission of
completed CRFs
Work to GCP as defined by the ICH, FDA and local regulations
12.3 ETHICAL CONSIDERATIONS 143