PSG Credentialing Program

CRITERIA TO BE A PSG TREATING SITE INVESTIGATOR IN A CLINICAL TRIAL

Individuals with an MD, DO, NP or PA degree (so long as permitted, according to applicable state law in the state where they practice, to independently diagnose and treat patients and prescribe medication) who demonstrate commitment to the care of people with Parkinson’s disease by meeting the criteria stated below:

  1. Clinical practice includes significant PD experience or research which is either clinical or basic science related to PD

  2. Must have completed a movement disorders fellowship of at least 1 year through an academic center or equivalent experience (such as 5 years of clinical experiences that includes 100 patients per year)

  3. Ongoing demonstrated commitment to continuing education in PD

  4. PD as a significant percentage of your practice

  5. Experience in clinical trial conduct, including having served as the Principal Site Investigator for a clinical trial with responsibilities including:

    • Responsibility for IRB submission

    • Completion of training in GCP

    • Conducting all study activities required of the investigator

    • Collaboration with and supervision of the coordinator for completion of CRFs

    • Knowledge of an experience with reporting AEs and SAEs

    • Meeting monitor(s) to identify and correct deficits in study conduct

Proviso 1:  An individual who has never served as a site principal investigator in a clinical trial may be approved with the proviso that they are to have an experienced PSG investigator at the site serve as their mentor, “Administrative PI,” for their first PSG trial. The Administrative PI must agree in writing to serve as a mentor and attest to the following:

  • Acceptance of responsibility for actively ensuring that the applicant investigator gains appropriate knowledge and experience as a study PI (see criteria above)

  • Personally being in current good standing with any federally regulated requirements for the conduct of clinical trials

  • Willingness to submit their credentials to the PSG Credentials Committee for review

  • Willingness to abide by the PSG confidentiality and conflict of interest policies for the study in which they serve as mentor

Proviso 2:  Any non-physician, including a NP or PA, who is approved as a treating investigator must have a PSG member neurologist at their institution with whom they can consult. (If an approved non-physician treating investigator moves to a non-PSG site, they would be required to have the new institution approved by the Credentials Committee, and in addition, a neurologist at that institution would need to independently be reviewed/approved by the Credentials Committee as a potential PSG investigator before the non-physician could begin a PSG trial at the new institution)

CRITERIA TO BE A PSG INVESTIGATOR IN OBSERVATIONAL, OR NON-PHARMACOLOGICAL COGNITIVE OR BEHAVIORAL CLINICAL TRIALS

Individuals with a non-medical graduate degree (e.g. PhD, LCSW social worker, or MD or DO that do not meet PSG Treating Investigator Criteria), who demonstrate commitment to Parkinson’s disease by meeting criteria numbers 1,3, 4, 5, & 6 as stated above. An individual with a graduate degree, having no license to prescribe medication, may not be the Principle Investigator in a trial involving drugs.

All criteria to be a PSG investigator in an observational or non-pharmacological cognitive or behavioral clinical trials are the same as those for a clinical trial with the exception of criteria #2 which covers education. For non-drug trials, individuals must have a graduate degree, training, or experience relevant to PD or be a licensed NP or PA with experience relevant to PD.

Proviso 1 and 2 are applicable as mentioned above.

Proviso 3:  If an approved NP or PA without prescriptive authority moves to a non-PSG site, they will be required to have the new institution approved by the Credentials Committee. In addition, a neurologist at that institution will need to independently be reviewed/approved by the Credentials Committee as a potential PSG investigator before this individual could begin a PSG trial at the new institution.

HOW DO YOU START THE CREDENTIALING PROCESS?

Please review the list of documentation required below for PSG credentialing. All documents must be sent directly to the PSG Administrative Director.

WHAT IS THE TIMELINE FOR BEING PSG CREDENTIALED?

The PSG has a credentialing committee, which is comprised of 6 PSG investigators. They meet quarterly to review new applications: March, June, September, & December. Applications are due 30 days prior so that the committee has time to evaluate them. Immediately following the committee review session, applicants will be notified of their status. If approved as a PSG investigator, you will immediately be eligible to participate in PSG studies.