Sponsor Investigator

Responsibilities
Chapter 5

Sponsor - Investigators
Principal Investigators, who hold INDs, (Sponsor- Investigators)
Adhere to responsibilities in order to properly conduct the trials.
Qualified by education, training and experience to assume responsibility for the proper conduct of the
study
Should have qualifications prescribed by the applicable regulatory requirement(s), and should provide
evidence of such qualifications
Sponsor-investigator is responsible for [21 CFR 312.60]:
investigator statement of
assurance, the investigational plan, and applicable regulations.
welfare of participants under the investigators care.

Submissions
1) The Overall Principal Investigator (SI).
2) Submitting all regulatory documentation to the IRB,the FDA and other sites.
3) Initial submission of the protocol to the IRB and FDA,
Informing the assigned study team of the FDA contact and IND number,
Furnishing the study team with the original 1571 and 1572,
For providing the initial approval letter from the FDA stating that the PI is not exempt from holding the
IND.
Coordination of the regulatory paperwork
IRB Continuing Review (CR) Form
IRB Amendment Form
Serious Adverse Event (SAE) Reports
IRB SAE form
MEDWATCH 3500A Form.
Selecting other qualified investigators
Providing them with the information they need to conduct the studies properly
Monitoring of the studies
Ensuring the studies are conducted in accordance with the general investigational plan and protocols
contained in the IND or IDE application
Maintaining an effective IND or IDE with respect to the investigations
Ensuring that FDA and all participating investigators are promptly informed of significant new adverse
effects or risks with respect to the investigational agent.
A sponsor-investigator is responsible for fulfilling all of the investigator obligations
General Sponsor Obligations (21CFR 312.5)
Conduct investigation according to investigational plan and protocols contained within the IND.
Ensure participating investigators are provided with the information they need to conduct the
investigation properly.
Ensure proper monitoring of the investigation.
Promptly inform FDA and all investigators of significant adverse events (AEs) or risk.
Maintain adequate records, reporting and monitoring of the investigation to include product
accountability.
Maintain an effective IND which complies with all regulatory requirements.
General Investigator Responsibilities (21 CFR 312.6):
Protect the rights, safety and welfare of subjects
Conduct investigation according to the signed investigator statement (Form 1572).
Control drugs under investigation.
Obtain informed consent of each human subject
Assure of IRB review
Investigator Obligations
Protocol Compliance
Subject Recruitment
IRB/IEC
Records
Medical Care
Investigator
Reports
Investigational product
Trial Conduct
Qualified
Everything is linked by Investigator.
Responsibilities
1. Medical Care of Trial Subjects :
responsible for all trial-related medical (or dental) decisions. adverse events, treatment during
intercurrent illness(es) ,
Premature withdrawal -ascertain the reason(s) while fully respecting the subjects rights.
2. Communication with IRB/IEC
All documents subject to review - written and dated approval/favourable opinion from the IRB/IEC for
the trial protocol, written informed consent form
A current copy of the Investigator's Brochure
3. Adequate resources : Potential number of recruitment, sufficient time to properly conduct and
adequate facilities and staff
4. Delegation of Responsibilities (log)
5.Compliance with Protocol
Sign the agreement.
Adhere to protocol
Deviations - to avoid immediate hazard should be notified Sponsors/IRB/ Regulatory authorities
Protocol amendment(s)
6.Investigational Product (IP)
Accountability
Drug Inventory Records
Storage
Monitor correct use by trial subject
Drug Return
7.Randomisation Procedures and Unblinding
Follow the trial's randomization procedures
Code opening - accordance with the protocol.
Any premature unblinding immediately report to sponsor
8.Obtaining and Documenting Informed Consent
Ethical principles and GCP
Revisal of important new information.
ICF should be approved by IRB/IEC
language used should be understandable to subject/LAR/Impartial Witness
Ample time & Opportunity Clear the doubts
Not to influence a subject to participate
Signature and date - subject /LAR, and by the person who conducted the informed consent discussion.
Informed Consent Discussion
Experimental nature, purpose, treatment(s) and the probability for random assignment, alternate
treatment(s), the trial procedures, subject's responsibilities, foreseeable risks.
The compensation and/or treatment available in the event of trial-related injury.
Voluntary participation and expected duration
Records for verification to the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies)
Confidentiality of subjects identity in publications.
The person(s) to contact
Procedures
Copy of the signed and dated written informed consent form.
Legally acceptable representative
Subject is unable to read, minors, or patients with severe dementia , non-therapeutic trials , emergency
situations when prior consent is not possible.
Impartial Witness Subject or subjects legally acceptable representative is unable to read.
Documentation on informed consent.
Monitoring
Ensure that the trial is conducted and documented properly
Verifying that the investigator has adequate qualifications and resources and remain adequate
throughout the trial period,
facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the
trial
Verifying, for the investigational product(s):
9.Records
Data consistency with the source documents -accuracy, completeness, legibility, and timeliness of the
data reported
Correction to a CRF should be dated, initialed, and explained
Retention of Essential documents - applicable regulatory requirements
Financial aspects -agreement between the sponsor and the investigator/institution
10. Reports
Progress Reports: To the sponsor, the IRB/IEC
Safety Reporting : Serious adverse events (SAEs) should be reported to the regulatory authority(ies) and
the IRB/IEC.
Adverse events and/or laboratory abnormalities report to sponsor
Premature Termination or Suspension of a Trial to sponsor , IRB/IEC
Final Report(s) by Investigator
Audit
Independent of and separate from routine monitoring or quality control functions, should be to evaluate
trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.
Qualified by training and experience to conduct audits properly
Auditing Procedures : sponsor's written procedures
Documentation : Observations and findings of the auditor(s) should be documented.
Audit certificate
Noncompliance : Prompt action by the sponsor to secure compliance.