Person designated as lay person in EC must be present to fulfil quorum

Please advise on the below mentioned: GCP training requirements i.e., what is considered appropriate training and are there any re-training requirements? Are there any enforcement actions on investigators on lack of GCP training? Are there any enforcement actions against the sponsor/CRO for not ensuring appropriate GCP training?

FDA does cite training deficiency of monitors/site/investigator in inspection findings. Actions would be voluntary action indicated or official action indicated. Regulations do not specify any requirements for training or retraining.

See below a response from US FDA

The Food and Drug Administration's (FDA's) regulations do not contain specific training requirements for sponsors, investigators or staff. The regulations broadly require that clinical investigators be qualified by education, training and experience to perform their assigned duties, but FDA's regulations are not explicit as to what this means. Sponsors are given discretion in determining what qualifications will be needed, based on the general recognition that this would include education, training and experience pertinent to the particular clinical study and its design and execution, as well as familiarity with human subject protection (HSP) regulations, record keeping, data integrity, and good clinical practice (GCP) standards and requirements.

FDA Guidance on Investigator Responsibilities 2009 covers some training aspects.  

In assessing the adequacy of supervision by an investigator, FDA focuses on four major areas: (1) whether individuals who were delegated tasks were qualified to perform such tasks, (2) whether study staff received adequate training on how to conduct the delegated tasks and were provided with an adequate understanding of the study, (3) whether there was adequate supervision and involvement in the ongoing conduct of the study, and (4) whether there was adequate supervision or oversight of any third parties involved in the conduct of a study to the extent such supervision or oversight was reasonably possible.

The investigator should maintain a list of the appropriately qualified persons to whom significant trial-related duties have been delegated. This list should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform delegated tasks

The investigator should ensure that there is adequate training for all staff participating in the conduct of the study, including any new staff hired after the study has begun to meet unanticipated workload or to replace staff who have left. The investigator should ensure that staff:

Are familiar with the purpose of the study and the protocol.

Have an adequate understanding of the specific details of the protocol and attributes of the investigational product needed to perform their assigned tasks

Are aware of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects

Are competent to perform or have been trained to perform the tasks they are delegated

Are informed of any pertinent changes during the conduct of the trial and receive additional training as appropriate

If the sponsor provides training for investigators in the conduct of the study, the investigator should ensure that staff receive the sponsor’s training, or any information (e.g., training materials) from that training that is pertinent to the staff's role in the study.

Can an EC member, who is a lay person on the panel, be absent for protocol review meetings and in such situations can the member secretary of the IEC or any IEC member act as a lay person?

No. This is not acceptable. A person designated as "lay person” in EC composition must be present to fulfil the quorum requirements. Nobody else can act as lay person unless he/she is serving as lay person in the EC and has been mentioned in the composition. If a lay person is absent, the quorum is not fulfilled and the EC approval is invalid.

One of the members from the total five members is absent during review of the protocol and the EC members vote to approve the protocol, with one of the present members playing dual role to compensate for the absent member. Can a member of ethics committee play dual role in the absence of the other?

No. Each member of EC has an assigned role for each representation. A member cannot play dual role. The representation must be as listed in the EC SOPs.  

Can a member of an EC exchange the role for reviewing different protocols. i.e. a member is acting social scientist while reviewing one protocol and same member acting as lay person for reviewing another protocol?

No. Lay person and social scientist are specific and different roles. These have to be defined in the SOPs. A person cannot change the role in the meeting.

If a subject suffers from an adverse event of vomiting associated with the abdominal pain and nausea. The one event was followed by other and sometime they were occurring in the same time simultaneously. Can we combine these events in single AE?

If all these events have occurred around the same time and if there is suspicion of a common diagnosis e.g. gastritis, then all the events can be combined under one diagnostic term.