CLINICAL TRIALS
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INFORMATION for PHYSICIANS...


Clinical Trial Contracts

Clinical Trials of Virginia establishes contracts with the pharmaceutical industry and/or Contract Research Organization (CRO) on behalf of the physician investigator for clinical studies closely matching his/her medical specialty.

A physician is considered as a prospective Principle Investigator (PI) when CTOV submits his/her curriculum vitae (CV) to a pharmaceutical sponsor.  A study protocol is released through CTOV for review by the physician, after all involved parties have signed an agreement of confidentiality with the Sponsor.  Physicians are not obligated to accept any study that CTOV presents.  For those studies that are pre-accepted by the P.I., a contract with terms and methods of payment to the physician will be drafted by Clinical Trials of Virginia.


Investigator's Responsibilites

Regulatory documents (IRB application, Informed Consent Form, FDA form 1572, etc.) are completed by CTOV management and are subject to review and approval by the P.I.  Federal regulations regarding the role of the P.I. are outlined as follows:

  • An investigator who is qualified by training and experience shall be selected as an appropriate expert to investigate the study drug.  At the onset of a clinical trial the investigator makes a committment to abide by the laws and regulations governing clinical studies.  The investigator conducts the study in accord with the protocol and may deviate from this protocol only after notifying the Sponsor, except when the safety, rights, or welfare of the subject is threatened.  The investigator will strictly adhere to the Good Clinical Practices (GCP's) and Food and Drug (FDA) regulations at all times when conducting the study.
  • The PI will personally conduct and/or supervise the study and ensure that all sub-investigators are educated about and comply with the laws and regulations governing the clinical investigation.
  • The PI is responsible for informing study subjects that the drug is investigational and to assure that all adverse experiences, changes in research activitiy, or un anticipated problems which may occur during the study are reported to CTOV, the Sponsor, and the IRB.
  • The PI must read and understand the information contained in the Investigational Drug Brochure (IDB), including risks and side effects of the drug.
  • The physician (PI) has the obligation to review, sign, and date all medical data generated for each subject during the course of the trial.

 


Clinical Trials of Virginia Responsibilities

  • CTOV will select the PIs to conduct the clinical trial based upon qualifications, experience, and clinic patient population.
  • CTOV will provide the PI with experienced clinical trial coordinators for the course of the study.
  • CTOV shall ensure that the selected IRB complies with all regulations governing the conduction of the clinical trial; the IRB shall be responsible for the initial and continuing approval and periodic review of the clinical study.
  • CTOV will be responsible for submitting relevant data to the IRB regarding initiation, progress and/or termination of the study as well as a final report.  Serious adverse events and any changes to the research protocol will be communicated with the IRB through CTOV.
  • CTOV personnel will control and dispense the study drug to the enrolled patients under the supervision of the PI.  The Drug Accountability log will be maintained by a CTOV study coordinator.  Neither the PI nor any personnel involved with the study will supply the investigational drug to any individual not authorized to receive it.
  • A clinical research coordinator is assigned to an investigate site by CTOV to enroll study participants and to perform procedures required by the protocol under the supervision of the PI.
  • If study appointments need to be schedule at times other than the regular office hours, the study coordinator as well as other CTOV personnel must be given access to the office.
  • CTOV study coordinators will be accessible to patients by a 24 hour number.