Responsibilities of Center Personnel

This Standard Operating Procedure defines the responsibilities of the research team for conducting clinical studies at this investigative site.  It identifies administrative accountability as well as general responsibilities of the research team and of individual team members for fulfilling regulatory and clinical requirements.

 Primary Investigator:  An investigator that oversees a group of consulting investigators.  A primary investigator is accountable for all responsibilities of a primary investigator, consulting investigator, research coordinator and any other personnel involved in this study.  A primary investigator is accountable to the principal investigator to ensure proper communication regarding the study for the entire duration of the study.

 

Principal Investigator: The main investigator taking sole responsibility for overseeing other investigators involved in the study and ensuring that the clinical study protocol is followed at his/her institution.  The principal investigator is accountable for all responsibilities of a principal investigator, primary investigator, consulting investigator, research coordinator, and any other center personnel involved in the study.  The principal investigator is responsible for communicating study information to and from the ethics board.

 Center Study Coordinator aka Center Research Coordinator: the Center Research Coordinator oversees research at their specific site and has a thorough knowledge of the study protocol, ensures proper patient eligibility, consent and enrollment, ensures CRFs are submitted correctly and on time, maintains patient and administrative file documentation, is responsible for obtaining and maintaining Ethics Board approval and documentation and acts as the contact person at the center.

 

 

 

 

 

Applicable References to SOPs, Regulations or Guidelines

    21 CFR 312.53 Selecting investigators and monitors

21 CFR 312.60 General responsibilities of investigators

21 CFR 312.62 Investigator recordkeeping and record retention

21 CFR 312.68 Inspection of investigator’s records and reports

FDA Information Sheets October 1998

Frequently Asked Questions, Continuing Review After Subject Approval, Recruiting Study Subjects, A Guide to the Informed Consent, Sponsor-Investigator-IRB Interrelationship

 

May 1997 International Conference on Harmonization; Good Clinical Practice: Consolidated Guidelines

 

 

4.0         Responsibility

 

This SOP applies to those members of the clinical research team involved in supervising, managing or conducting study related activities.  This includes the following:

Administrative responsibilities inclusive of 

  1. PI
  2. Research manager
  3. Research nurse/coordinator
  • Participate as appropriate in the hiring and training of individuals recruited as members of the research team.
  • Assign trained research nurse/coordinators to manage each clinical study planned or ongoing at this site.
  • Design appropriate recruitment strategies and track study enrollment.
  • Communicate with the IRB as appropriate.

General Responsibilities of the Research Team inclusive of
  1. PI
  2. Sub-investigator
  3. Research manager
  4. Research nurse/coordinator
  5. Support staff
  6. Core lab

Conduct clinical studies according to FDA regulations and guidelines and SOPs of this clinical site and according to the policies and procedures of this institution, if appropriate.

Ensure that the PI is informed in a timely manner of all study-related activities through: meetings, memos, reports and/ or face to face communication.

Ensure the safety and welfare of study subjects by being knowledgeable about ongoing study protocols and investigational articles.

All investigators and covered research personnel must comply with federal regulations governing disclosure of personal, professional or financial interests in a research study that may impact upon its conduct, evaluation or outcome.

Individual Responsibilities within the Research Team

 

PI                                        Consent patients

Sub PI

Sign Form FDA 1572 to acknowledge responsibilities as defined by the regulations (attachment A, Form FDA 1572)

Supervise members of the research team qualified by their education and training to accept these responsibilities for study – related activities not performed by the PI.

Ensure the safety and welfare of study subjects by being knowledgeable about ongoing study protocols and investigational articles.

Assign trained research nurse and/or coordinators to manage each clinical study planned or ongoing at this site.

Meet with auditors (internal and external) at the conclusion of the audits to review findings.

 

Research Nurse Coordinator

Data Manager

Develop organizational aids and checklists to facilitate patient recruitment and enrollment as well as the collection of complete and accurate study data.

 

Manage participation according to ethical, regulatory, and protocol-specific requirements.

 

Maintain the regulatory and study files for each research subject.