INVESTIGATOR
DEFINITION
An Investigator is a person responsible
for the conduct of a clinical trial at a trial site.
If the trial is conducted by a team of individuals at the site, the
investigator is the leader of the team and is called the Principal
Investigator (PI).
REGULATORY BASIS
According to Food and Drug Administration
regulations (21 CFR 312), Indian GCP Guidelines, and International
Council for Harmonisation-GCP, sponsors must select appropriately
trained, qualified, and experienced investigators.
ROLES AND RESPONSIBILITIES OF AN
INVESTIGATOR
1. INITIATING A CLINICAL TRIAL
a) Contracts and Agreements
- Enter into all clinical
trial–related agreements (clinical trial agreement, budget,
confidentiality agreements).
- Ensure agreements comply with
applicable regulatory and ethical requirements.
b) IEC / IRB / EC Approval
- Obtain approval from IEC/IRB/EC
before initiating the trial.
- Ensure subject enrollment
begins only after written approval.
c) Constituting the Study Team
- Select and supervise:
- Co-investigators
- Clinical Research Coordinator
(CRC)
- Study nurse
- Pharmacist (if applicable)
- Ensure all team members are
qualified and trained.
d) Planning and Ensuring Resources
- Ensure availability of:
Adequate infrastructure and
facilities
- Qualified staff
- Time commitment
- Equipment and trial supplies
- Assess feasibility of
conducting the trial at the site.
e) Trial Training
- Attend investigator meetings
and protocol training.
- Ensure the study team is
adequately trained on:
- Protocol
- SOPs
- Safety reporting
- GCP requirements
2. CONDUCT OF THE TRIAL
- Recruit eligible subjects
according to the protocol.
- Obtain freely given
informed consent before any trial-related procedure.
- Provide appropriate medical
care to trial subjects.
- Ensure strict protocol
compliance and adherence to the schedule of events.
- Comply with ICH-GCP and
applicable regulatory requirements.
- Maintain proper investigational
product (IP) storage, handling, dispensing, and accountability.
- Follow approved randomization
and blinding/unblinding procedures.
- Communicate with:
- IEC/IRB/EC
- Sponsor and CRO
- Facilitate:
- Data collection
- Monitoring visits
- Audits and inspections
- Document:
- Protocol deviations
- Violations
- Non-compliance
- Ensure subject
confidentiality at all times.
- Maintain financial records and
trial-related payments.
3. SITE CLOSURE RESPONSIBILITIES
- Submit final study report to
IEC/IRB/EC.
- Provide all required documents
and data to the sponsor.
- Return unused investigational
product and trial equipment.
- Reconcile grants and financial
records.
- Archive essential trial
documents for the period specified in:
- Regulations
- Sponsor agreement
- Manage premature
termination or suspension of the trial, if applicable, and notify
all stakeholders.
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