Once upon a time, there lived a renowned medical research physician, much like Joseph Saponaro, MD, DABIM, FACP, CPI, CCRI, CCRC, CCRP, who served as PI (Principal Investigator) for several industry sponsored INDs (investigational new drug) studies. He was responsible for many sub-I's (sub-investigators) along with research subject volunteers. His work often kept him up very busy, up late at night lecturing and back in the office again early in the morning.

One night he had to present a lecture to a group of colleagues. His personal chauffeur, Mike, commented on the way how tired he looked; as he couldn't stop yawning and it was obvious hard for him to keep his eyes open. It was clear that he was burning the candle at both ends and that it was beginning to catch up with him that particular night.

Suddenly, Mike came up with a great plan. He noted that he had waited for the doctor in the back of the room many times when he gave the GCP (Good Clinical Practice) lecture. Mike said he had it memorized and he would be willing to present it. The tired doctor agreed.

So, Mike stepped up to the podium while the good doctor put on the chauffeur's cap and coat, and proceeded to the back of the room to close his eyes for a while.

Mike the chauffeur did a very good job explaining Good Clinical Practice as developed by the International Conference on Harmonization. He described how the standards are affirmed by the investigator in filling out FDA Form 1572 for designing, conducting, recording and reporting of clinical trials that involve human research subjects. He provided a summary of instructions to PI's, sub-I's and investigator designates in performing a clinical trial involving a drug, biologic or device in accordance with the "Good Clinical Practice" standard. He further explained how adherence to this standard assures credibility of data, and well-being, safety and protection of the rights of research subjects engaged in clinical trials consistent with the Declaration of Helsinki. He went on to describe how professionals qualify to perform research by demonstrating appropriate training and experience to assure responsibility should provide evidence of such qualifications. In addition, he went on to describe how the research team should comply with GCP procedures and applicable regulations and how they should permit monitoring and auditing by the sponsor and the appropriate regulatory agencies. Also, to maintain a list of appropriately qualified persons who have delegated trial-related responsibilities. He went on to describe GCPs regarding investigator resources including: demonstrate potential for recruiting required number of subjects; have sufficient time to properly conduct and complete the trial within the agreed period; must have adequate number of qualified personnel and facilities to conduct the trial properly and safely; investigator must make sure personnel assisting in the study are adequately informed about the protocol, investigational product and trial-related duties and functions. The GCP standard for the PI's medical care of the trial subjects include: A qualified physician, who is an investigator or sub-investigator for the trial must be responsible for all trial-related medical decisions; During and following subject's participation in a trial, the investigator should ensure that adequate medical care is provided to a subject for any adverse events (including lab values); The investigator must inform the subject when medical care is needed for inter-current illness of which the investigator becomes aware; It is recommended that the investigator inform subject's primary care physician about subject's participation (subject's agreement to this requirement is required); If subject wishes to withdraw from the study, the investigator should make reasonable effort to ascertain the reasons, while fully respecting the subject's rights. Before initiating a clinical trial, the PI must have all the proper regulatory communication paper work with the IRB completed including: Written date approval letter for the trial period; Written and approved informed consent form; Consent form updates; Subject recruitment procedures (ie: advertisements); Any other information to be provided to the subjects; Provide a current copy of the investigator's brochure; If the investigator's brochure is updated, the investigator must supply a copy of the updated brochure to the IRB; Any other documents that are subject to review by the IRB. The investigator must comply with the GCP standard to follow the protocol: Stay in compliance with the protocol; if required, the protocol agreed by the regulatory authorities; Obtain approval from the IRB; Investigator should sign the protocol to confirm the agreement. The investigator should not implement any deviation from, or change the protocol without: Agreement from the sponsor; Prior review and documented approval from the IRB of an amendment except where necessary to eliminate an immediate hazard to trial subjects or when the changes involve only logistical or administrative aspects of the trial (ie: change in the monitor, change of telephone number, without IRB approval. However, as appropriate, the proposed protocol amendment should be submitted to: The IRB for review and approval; To the sponsor for agreement; And if required, to the regulatory authorities.

In summary, Mike the chauffeur did a great job of going over GCPs while the his client, the real doctor rested comfortable in the back of the room. At the end, one of the doctors asked a question that Mike did not know the answer to. At first, Mike started to panic. After a short while, he got his wits about him and replied, "That's such an easy question that I'm going to let my chauffeur answer it!"