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#Medical device fda label expert witness cv trial#

All investigator sites where the participants are seen for trial procedures and the investigational product (IP) shipment address(es) recorded in section 3.Verify names, address(es), and other relevant information are correct for the following:.Note: It is the sponsor or contract research organization’s (CRO’s) decision whether to list supporting personnel, such as study coordinators, on the Form FDA 1572.As a rule, you should list any individual member of the clinical trial physician team who is designated and supervised by the PI to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).Check that all investigators and other pertinent study staff are recorded in section 6.Validate that the PI’s affiliation on the CV is consistent with the site address on the Form FDA 1572.

#Medical device fda label expert witness cv license#

The Form FDA 1572, CV, financial disclosure form, and medical license should all show consistency regarding the PI’s name.For more information on completing the Form FDA 1572, see FDA Information Sheet Frequently Asked Questions – Statement of Investigator (Form FDA 1572). Ex-US sites do not use Form FDA 1572s, so sponsors may need to request these sites sign a different document. Note that the Form FDA 1572 is unique to US-based sites.

Certify that staff are trained on the study before performing study-related duties (cross-check against site initiation visit attendance and subsequent training logs).

Confirm that the log is up to date, reflecting additions and deletions in staff, using good documentation practices.

Validate that delegated duties are signed and dated by the PI before involving staff in the study.

A cross-check ensures curriculum vitae (CVs) and medical licenses (if appropriate) are on file and current. E.g., non-medical personnel should not assess adverse event causality or confirm the clinical significance of lab results.

Review and confirm the staff are qualified to carry out delegated duties.

Remember: It is the principal investigator’s (PI’s) responsibility to ensure study-related activities have been delegated appropriately. Staff turnover can often impact the completeness of this log.

The delegation log is one of the most common sources of issues during an audit.

Site responsibility log (SRL) or delegation log.

Below are examples of specifically what auditors/inspectors are looking for during an audit. If documentation is incomplete, sites run the risk of regulatory inspection findings such as a Form FDA 483. Essentially, the auditor should be able to “reconstruct” the trial based on the documentation in place at the site. In addition to checking that the minimum requirements stated in ICH E6 (R2) section 8 are met, auditors also check the presence and content of a variety of documents. The ISF contains essential documents that permit evaluation of the conduct of the clinical trial.

This blog outlines the details to look out for when preparing your investigator site files (ISF) for an audit. Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated.