Study staff are persons who assist the Principal Investigator (PI) in the conduct of the clinical trial. Examples of study staff may include sub-investigators, clinical research coordinators, research assistants, pharmacists etc. Study staff should be adequately qualified (by education, training and experience), informed about the protocol, and delegated by the Principal Investigator.
The roles, responsibilities and signatures of all study staff should be captured in a signature sheet. Curriculum vitae, financial disclosure forms and training documentation should be maintained on file. Refer to your relevant Institutional Review Board (IRB) for minimum training and financial disclosure requirements.
It is ideal for all study staff to be delegated to be part of the study team. A pragmatic and reasonable approach may be considered for large teams (e.g. radiologists, nurses, pharmacy technicians). This involves the following:
- If the study procedure is performed in accordance with the protocol, the PI may delegate a staff of supervisory position (e.g. head of department, nurse manager or pharmacist) to be part of the study team. The staff in the supervisory position should be trained on the study protocol and be responsible to train the study staff under their care on the protocol and basic Good Clinical Practice (GCP). Training documentation should be maintained accordingly.
- If the study procedure is performed in accordance with standard of care, there should be documentation available on file to indicate the involvement of these departments and staff, with the authorisation of the PI. It would not be mandatory to train these staff on the study protocol, but it would be recommended to train these staff on basic GCP and training documentation should be maintained accordingly.
Note: Basic GCP training should be tailored to the needs of the staff and may include:
- Documentation, e.g. ALCOA principles (i.e. Accurate, Legible, Contemporaneous, Original and Attributable), amendments
- Record keeping
- Reporting of adverse events and non-compliances
A Principal Investigator (PI) is a qualified practitioner, who is qualified by education, training and experience, and has adequate resources to conduct a clinical trial. A qualified practitioner is a locally registered medical practitioner under the Medical Registration Act or a registered dentist under the Dental Registration Act.
For clinical trials assessing investigational products in specialised therapeutic areas, the PI should be at least an Associate Consultant (AC) or above in the specialised therapeutic area. This is because clinical trials in such therapeutic areas usually involve complex diagnostic evaluation of the disease condition, or study procedures that require specialised skills. A suitably qualified AC and above would have sufficient training and experience to conduct such clinical trials properly, as well as handle unforeseen adverse events or difficulties arising from the conduct of the clinical trial.
For clinical trials assessing registered therapeutic products or licensed medicinal products, the PI may be general practitioner where in clinical practice, he/she would be using the product.
A PI should have a level of authority to supervise the clinical trial in addition to being able to make independent medical decisions during the trial. The level of supervision should be appropriate to the nature of the trial and the subject population.
If the registration condition requires the doctor to "work under supervision", the doctor would be required to submit a statement from the doctor's supervisor indicating support for the doctor's involvement as the PI of the study, along with the clinical trial application to us.
Regulatory obligations of a PI
The regulatory obligations of a PI conducting a clinical trial are as follows:
- Conducts clinical trials in compliance with the protocol, applicable regulations, guidelines such as Good Clinical Practice (GCP), and standard operating procedures
- Conducts clinical trials at specified locations
- Responsible for adequate medical or dental care, and making trial-related medical or dental decisions
- Obtains informed consent from subjects
- Keeps adequate essential documents
- Declares financial interest to IRB
- Reports non-compliances to IRB, if required
- Reports serious adverse events within stipulated timelines to sponsor, and IRB if required
Change of PI
An amendment application for change of PI must be submitted to us and the IRB prior to implementing the change.
We recommend a change of PI in the following situations if the PI is away on extended leave for more than four months:
- The PI is also conducting multiple clinical trials concurrently.
- The clinical trial is a complex clinical trial.
- A large number of subjects have been enrolled into the clinical trial.
- The clinical trial involves a subject population that is critically ill.
- The clinical trial is conducted by inexperienced site staff.
It would be recommended to complete an end date for all study staff on the current Signature Sheet, and complete a new Signature Sheet for all study staff to be authorised by the new PI.
Medical or dental decisions to be made by an investigator
An investigator, who is a qualified physician, is responsible for the medical or dental care given to the subject and for all trial-related medical or dental decisions made on behalf of the subjects. Examples of these decisions include the following:
- Obtaining informed consent
- Confirming subject eligibility
- Performing physical examinations
- Reviewing laboratory results
- Reviewing ECG results
- Signing off case report forms
- Signing off data queries
- Safety reporting