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:
Clinical practice includes significant PD experience or research which is either clinical or basic science related to PD
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)
Ongoing demonstrated commitment to continuing education in PD
PD as a significant percentage of your practice
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)
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.
Below is a list of materials that are required to be uploaded along with your PSG credentialing application.
All primary investigators on PSG studies must be credentialed, as well as sub-investigators.
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.
Upon notification of your fully approved credentialing status, you may immediately begin participating in any/all PSG trials/studies with the exception of non-treating investigators, who may only participate in observational studies, in non-pharmacological cognitive or behavioral trials, or as the primary rater investigator in an interventional trial (in which another SI is fully responsible for treatment and clinical management).
Upon notification of your provisional approval, you must email the PSG Administrative Director with the name of the “admin SI’ at your site who you will be mentoring/overseeing you on your first trial/study as a PSG investigator. Upon completion of your first study, your admin SI will be required to complete the Provisionally Approved SI Review Form, which will then be sent to the Administrative Director/Credentialing Committee. Pending satisfactory performance, your membership will then be changed to Fully Approved.
Upon notification of your “study-specific” approval, you will be able to participate in ONLY the study/trial specified on your credentialing letter. Your “study-specific” status in the PSG database will be end-dated upon the completion of that specific study/trial. Should you wish to participate in future PSG studies, you may re-apply for full approval by completing the credentialing application process again with updated documents.