ROLES AND RESPONSIBILITIES OF THE INVESTIGATOR
Investigator:
A person is responsible for the conduct of clinical trials at a trial site.
Principal investigator:
If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Sub investigator:
Member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and to make important trial-related decisions.
RESPONSIBILITIES OF THE INVESTIGATOR:
Investigators should be qualified by education, training, and experience.
The investigator shows all the up-to-date documents to IRB/IEC.
The investigator should be thoroughly familiar with investigational products and their use.
The investigator should be aware of and should comply with, GCP and the applicable regulatory requirements.
The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authorities.
The investigator should maintain a list of appropriately qualified persons to whom he has delegated significant trial-related duties.
Adequate resources:
The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
The investigator should have available an adequate number of qualified staff and adequate facilities to conduct the trial properly and safely.
Medical care subjects:
Responsible for all trial-related medical decisions.
During and following a subject’s participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events.
Informed the subjects about all the risks and health problems that can occur during the trial before they join the trial.
If the subject has a primary physician and he wants to inform them, its the investigator's duty to inform them.
Communication with IRB/IEC:
Before initiating a trial, the investigator/institution should have written and dated approval /favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.
Compliance with protocol:
The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favorable opinion from the IRB/IEC of an amendment, except where the investigator, or person designated by the investigator, should document and explain the deviation from the approved protocol.
Investigational product(s):
The investigational products should be stored as specified by the sponsor and in accordance with applicable regulatory requirements.
Where allowed/required, the investigator/institution may/should assign some or all of the investigator/institution’s duties investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution.
The investigator/Institution and/or the pharmacist or the other appropriate individual, who is designated by the investigator/institution, should maintain records of the products delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused products. These records should include dates, quantities, batch/serial expiration dates and unique code numbers etc.
Randomization procedures and un-blinding:
The investigator should follow trials randomization if any, and should ensure that the code is broken only in accordance with the protocol.
If the trial is blinded, the investigators should promptly document and explain to the sponsor and premature unblinding of the investigational product.
Informed consent of trial subjects:
Should adhere to GCP and to the ethical principles that have their trial, the investigator should have the IRB/IEC’s written approval/favorable opinion written informed consent form and any other written information to be provided to subjects.
Neither the investigator nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial.
The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject, or the subject's legally acceptable representative and the impartial witness.
Records and reports:
The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
Any change or correction to a CRF should be dated, initialed and explained and should not obscure the original entry this applies to both written and electronic changes.
Progress reports:
The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC.
The investigator should promptly provide written reports to the sponsor, the IRB/IEC and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
Safety reporting:
All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., investigator’s brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports.
Premature termination or suspension of a trial:
If the trial is premature, terminated or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and where required by the applicable regulatory requirements, should inform the regulatory authorities.
Final reports:
Upon completion of the trial, the investigator, where applicable, should inform the institution, the investigator/institution should provide the IRB/IEC with a summary of the outcome of the trial, and the regulatory authorities with any reports required.
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