QRTI GCP New Page

QRTI Newsline --- Wednesday September 8, 2010

Assessing the Qualifications of Study Personnel

By Rochelle L. Goodson

A review of recently issued inspectional observations for clinical sites revealed an increase in citations of inadequate delegation by Principal Investigators. Routine regulatory tasks and monitoring responsibilities include the assessment of study personnel. In addition to the initial qualification assessments, milestone activities throughout the clinical trial process present opportunities for re-assessment of study personnel qualifications. Listed below are some of the opportunities to conduct these evaluations:

Regulatory Package Review

The first line of defense for identifying potential inappropriate delegations of responsibility is during the review of the regulatory documents obtained prior to study start. The purpose of collecting these documents, prior to shipping investigational supply, is to enable an intense evaluation of the training, education, and qualification of the site staff. Listed below are the items requiring routine evaluation:

CVs of the Principal Investigator (PI) and Sub-investigator (Sub-I) to determine that medical specialty is appropriate for the study;
Form FDA 1572s to determine if appropriate staff are listed;
U.S. medical licenses for physicians;
Current, state-issued licenses for all physicians, nurse practitioners, physician assistants, registered and practical nurses;
DEA 223 Controlled Substance License for at least one of the key personnel listed on a Form FDA 1572, if applicable.

Pre-study Assessment Visit

Among the essential goals of a Pre-study Assessment Visit is to ascertain the capabilities of the Principal Investigator and staff. Therefore, it is also the optimal time to determine if the staff has the capability of performing the required study procedures. A comprehensive assessment of the training, education, and qualification of the staff members provides more value than performing the perfunctory task of obtaining the names and titles of staff and/or having the staff sign and date the Site Delegation Log. In addition, the conduct of study staff interviews are vital to determine if their training and experience supports the tasks and study procedures that are assigned for the study. A review of the following documents prior to study start permits the assessment of staff qualifications and associated certifications:

Current CVs;
Training documentation pertinent to the study;
Documentation of GCP training; and
Study Coordinator certifications, etc.

Site Initiation Visit

A Site Initiation Visit provides an opportunity to assure that the same staff members that were present at the Pre-Study Visit still have the same study responsibilities. An interview of any new study staff should also include an assessment of their qualifications. Monitors should ensure that all staff listed on the Form FDA 1572 have been listed on the Site Delegation of Responsibility Log and ensure that all licenses and/or certifications are still current (unexpired). Most importantly, assure that all staff members have received training on the protocol and that documentation of the training is available.

Finally, keep in mind the following regulations and ICH GCP Guideline sections that underscore the need to address the issue of qualifications and delegated responsibilities:

21CFR§312.50;21CFR§312.53; 21CFR§312.1.3
ICH GCP (E6) Sec.2.8; ICH GCP (E6) Sec 4.1

An important reminder for clinical research personnel, such as project managers and monitors, is to reexamine the good clinical practice implementations (standard operating procedures and Clinical Monitoring Plans) periodically to assure that appropriate procedures are available for assessing staff qualifications. Proper SOPs and their implementation will not only avoid a citation by FDA but will demonstrate due diligence efforts to promote subject safety and welfare.