The investigator is an individual who plays an important role in clinical research or investigation. He will have plenty responsibilities to go through. The investigator is also responsible leader who looks after the team members under investigation. The investigator can be any individual with appropriate education, training and experience. In addition, he should provide documents of such qualifications.
The investigator has to know about the test product, regulations and responsibilities. He should make way for the sponsor and regulatory authorities to monitor the trials. The investigator will recruit the subjects required for clinical trial by explaining the ICF (Informed Consent Form) with oral communication or by the written document. He should not convince the subject to sign IC form. And the subjects are provided enough time to go through the form.
After the communication is done between the subject and the investigator, they both will sign the written summary or written document. The investigator gives assurance about withdrawing the trial at any time. He allows the subject to take their witness for the communication if necessary. In such case even witness should sign the written summary or written document. In paediatric studies, Investigators concentrate on vulnerable subjects (children). Children subjects have another form called Informed Assent. In this the investigator will do oral communication with children’s parents or guardians. In such instances, a typical signature of the child is not required.
The investigator should have the list of appropriate number of subjects who have signed for a voluntary participation in clinical trials. The investigator will appoint Clinical Research Coordinator (CRC), who submits all the research documents to IRB. And the investigator must be responsible for all trial-related medical decisions. FDA will ask the investigator to sign 1572 form for phase 1 to phase 3. The Investigator will carry approval letter for the trial, ICF, a copy of IB, a list of subjects participating the trial and protocol copy which is approved by IRB. The investigator cannot make any changes in protocol, if made then it should be approved from IRB with agreement by the sponsor. He also looks after IP accountabilities i.e., how much product is given, used, remaining and destroyed or given back to the sponsor.
The product should be stored with applicable regulatory requirements. Mainly the subject participating in the trial should know the benefits of the product and how to use it as per the instructions mentioned. The investigator can do Blind masking in certain circumstances. ICF form should be formed according to Good Clinical Practice (GCP). The investigator provides the sponsor all the information of subjects in the trial in Case Report Form (CRF), which must contain correct, complete, accurate information. He keeps the CRF of subjects confidentially. He should document each and everything done in the clinical trial. The Sponsor will guide the investigators on procedures involved in the clinical research and tell them till what duration the source documents should be kept safe.
Regarding the financial aspects in the trial, there is an agreement which is signed between the sponsor and the investigator. For every different clinical site different investigators are appointed. At last they compile all the data of different clinical sites, which results in large data. Adverse effect in a clinical trial is usually rare case. If happened so, then the investigator has to immediately report it to the sponsor. Followed by the subject’s identification code, name, address and contact number. In severity cases, they provide compensation to the subject. The investigator should inform the sponsor and the IRB, in case if he is including a new study in the clinical trial.
After the end of the clinical trial, the investigator as to provide a Final clinical study report and Final accounting IP to IRB, sponsor and regulatory authorities. To conclude, I personally feel that clinical research without an investigator is a coffee without sugar.