Responsibilities of Investigator :Responsibilities of Investigator Amol Khedkar B.Pharm M.Tech(Biotech) Email: amolkhedkar@gmail.com +91-9763921244 A Presentation on…………….


Investigator :Investigator Investigator: A person responsible for the conduct of the study at trial site. Investigator ia a person responsible for the rights, health and welfare of the study subjects. Principal investigator: In case the study is conducted by a team of investigators at one site or at multiple sites, the investigator who coordinates between the different investigators involved in the study is termed as the Principle investigator. Co-investigator: A co-investigator is a person legally qualified to be an investigator to whom the investigator delegates a part of his/her responsibilities.


Investigator’s Responsibilities :Investigator’s Responsibilities


Qualifying for being an investigator :Qualifying for being an investigator It is the responsibility of the investigator to participate in the study only if he/she is qualified as prescribed by the Medical Council of India(MCI). The investigator should provide a copy of the curriculum vitae and /or other relevent documents requested by the sponsor, the ethics committee, the CRO or the regulatory authoroties.


Provision of Infrastructure and Resources for the Study :Provision of Infrastructure and Resources for the Study It is the investigator’s responsibility to understand the time and other resource demands the study is likely to make and ensure they can be made available throughout the duration of the study. The investigator should also ensure that other studies do not divert essential subjects or facilities away from the study at hand.


Knowledge on Safety and Efficacy of Investigational Product (IP) :Knowledge on Safety and Efficacy of Investigational Product (IP) The investigator is responsible for being familiar with the safety, efficacy and appropriate use of the investigational product as described in the protocol, investigator’s brochure and other information sources provided by the sponsor from time-to-time. Compliance to Various Requirement The investigator should be aware of and comply with GCP, SOPs and the applicable regulatory requirements.


Medical Care of the Study Subjects :Medical Care of the Study Subjects Investigator or co-investigator for the study should be responsible for all study related medical decisions. Investigator has to ensure that adequate medical care is provided to a subject for any adverse events including clinically significant laboratory values or any inter-current illness during the study period. In case the subject is withdrawing prematurely from study, the investigator should make a reasonable effort to ascertain the reason while fully respecting the subjects rights.


Monitoring and Auditing of Records :Monitoring and Auditing of Records It is the responsibility of the investigator to allow monitoring and auditing of the records, procedures and facilities, by the sponsor, the ethics committee, CRO or their authorized representative or by regulatory authority. The investigator should maintain a list of appropriately qualified person to whom the investigator has delegated study related duties and ensure that people are adequately informed about the protocol, SOPs, the investigational products and their study related duties and functions.


Communication with Ethics Committee :Communication with Ethics Committee The investigator should promptly report to the ethics committee, the monitor and the sponsor: Deviations from or changes of, the protocol to eliminate immediate hazards to the subjects. Changes that increase the risk to subject and/or affecting significantly the conduct of the study. All serious and/or unexpected adverse drug reactions and adverse events. New information that may adversely affect safety of the subjects or the conduct of the study.


Compliance with the protocol :Compliance with the protocol The investigator/institution must agree and sign the protocol and /or another legally acceptable document with the sponsor, mentioning the agreement with the protocol and confirm in writing that he/she has read and understood the protocol, GCP and SOPs. The investigator may implement a deviation form, or change of protocol to eliminate an immediate hazard to study subjects without prior ethics committee approval. The investigator or person designated by him/her should document and explain any deviation from the approved protocol.


Accountability of Investigational Products :Accountability of Investigational Products Investigator has the primary responsibility for investigational product accountability at the study site by appropriate documentation of the inventory at the site, the use by each subject and the return to the sponsor or the alternative disposal of the unused product. These record should include dates, quantities, batch/serial numbers, specified storage conditions, expiry dates if applicable and the unique code number assigned to the investigational product packs and study subjects. Investigator should maintain records that describe that the subjects were provided the dosage specified by the protocol.


Selection and recruitment of Study Subjects :Selection and recruitment of Study Subjects The investigator is responsible for ensuring the unbiased selection of an adequate number of suitable subjects according to the protocol Check the institution records to assess the availability of a sufficient number of subjects. The investigator is responsible for maintaining a confidential list of names of all study subjects allocated to each study in addition to maintaining screening log and enrollment.


Informed Consent Process :Informed Consent Process The investigator has the duty to: Communicate to prospective subjects all the information necessary for informed consent. Exclude the possibility of unjustified deception, influence and intimidation. Seek consent only after the prospective subject is adequately informed. As a general rule obtain form each prospective subject a signed form as an evidence of informed consent


Records/Reports :Records/Reports The investigator holds the responsibility for ensuring accuracy, completeness, legibility and timelines of the data reported to the sponsor in the CRF and in all required reports. Any change or correction to the paper CRF or eCRF should be dated, signed and explained and should not obscure the original entry. The sponsor should provide guidelines to investigators on making such corrections. The investigator should retain records of the changes and corrections.


Progress Reports :Progress Reports The investigator holds the responsibility of submitting the study status on periodic basis as requested by the sponsor/CRO. All reporting made by the investigator should identify the subjects by unique code numbers assigned to the study subjects rather than by the subjects name, personal identification number and/or addresses.


Termination and Final Report :Termination and Final Report In case the investigator and sponsor agree to prematurely terminate or suspend the study for any reason, the investigator should promptly inform the study subjects, the ethics committee as well as the regulatory authorities. The study can be closed only when it is confirmed that all necessary documents are in the appropriate files. It is the responsibility of the investigator to inform about the study completion to the institution, the sponsor and the ethics committee.


THANK YOU :THANK YOU