Ich E9

Statistical Principles for Clinical Trials

Principal and Co-Investigator

PI (principal investigator) is responsible for conduct of trial, including ensuring safety of participants (patients or volunteers). Co - investigator(s) assist principal investigator. Both principal and co - investigators listed on FDA Form 1572.

Monitoring Activites

Monitoring of investigational sites required under FDA / CFR regulations and performed by IND sponsor: Investigator following protocol, subjects being informed of study and providing informed consent, data collected accurately and recorded, drug being stored, prepared and accounted for, and study documents maintained.

Monitoring Site Visits

Pre - study site visit, Initiation site visit, Interim monitoring visit, and Close-out site visit.

AE's and SAE's

Any adverse event (AE) associated with use of drug in humans, whether or not considered drug related. Serious AE is any AE that results; death, immediately life threatening, persistent or significant disability / incapacitating, requires or prolongs inpatient hospitalization, or congenital anomaly or birth defect.

Fig. 8.14. Definitions/Terms -1

companies and investigators is in identifying the disease parameters, drug factors, and research practices that the FDA/EMEA/MHLW deem important in the NDA/CTD process. Companies are well advised to become familiar with and take this information into account when designing and conducting clinical trials.

Abiding by the regulations and following the guidelines require a number of processes to be adopted when conducting a clinical trial. Specific research activities must be done in an orderly and specific sequence of events. In order for the study to run smoothly, all of the many diverse participants need to understand the process, especially what the key events and timing are. The end point is a complete and successful trial, finishing in a final study report to put into the NDA. Therefore, the many activities required are often mapped (i.e., a process map) to aid in the management and conduct of this clinical study process. An example of 23 basic and standard activities, required to conduct a clinical trial, is illustrated in Fig. 8.13. Many of these processes will be explained further in this chapter. The process map provides a basic understanding of the activities required to conduct a clinical trial. The process map includes a number of terms and abbreviations that may be unfamiliar to individuals outside the industry.

Fig. 8.14. Definitions/Terms -1

Twelve standard terms that are important to understanding clinical trial conduct are included in Figs. 8.14, 8.15, and 8.16. First, the PI (principal investigator) is the person who is responsible for the conduct of a trial. Although they are most commonly a licensed board-certified physician, pharmacologists (Ph.D.), clinical pharmacists (Pharm.D.), and other qualified health professionals are permitted to be PIs along with a physician co-investigator. The PI major responsibilities are first ensuring safety of participants (patients or volunteers), reporting to the IRB, conducting the trial according to good clinical practices (GCPs) and the particulars of the protocol, and collaborating with the company's project team members. Co-investigator(s) is/are person(s) assisting the principal investigator. Both principal and co-investigators must be listed on FDA Form 1572.

Monitoring of an investigational site is required under the regulations and is performed by the clinical operations staff of the sponsor of the IND [7, 8]. Monitoring activities include ensuring the investigator is following the protocol (inclusion/exclusion criteria, patient assignment to study groups,

IND Safety Reports

Report that sponsor of IND must submit to FDA and all investigators, when any SAE occurs which is unexpected and "associated with use of the drug", within 7 days of any unexpected fatal or life- threatening experience and within 15 days for all other safety reports.

IRB/IEC

Institution based groups that serve important role in protection of rights and welfare of human research subjects, and have been formally designated to review and monitor research involving humans. IRB has authority to approve, require modifications, or disapprove research.

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