Study Documentation
Primary content | Notes | Archive/ prior version |
|---|---|---|
| Clinical protocol current | This document provides an overview of the PPMI protocol. Much of the protocol initiated in 2010 remains the same but significant changes have occurred over the years. For an understanding of changes with each protocol amendment, review the archived versions linked here. Current linked protocol is Amendment 4. | Archive |
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Schedule of activities (SOAs) Healthy Control SOA Year 0-5 (AM 4) Healthy Control SOA Year 6+ (AM 4) Prodromal SOA Year 0-5 (AM 4) Prodromal SOA Year 6+ (AM 4) PD SOA Year 0-5 (AM 4) PD SOA Year 6+ (AM 4) OOC SOA (AM 4) | The frequency of study visits and what assessment occurred at each visit. Many of the schedule of activities and assessments initiated in 2010 remain the same but several changes have occurred over the years. For an understanding of changes made to the assessments and schedule of activities, review the archived versions linked here. | Archive |
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Case report forms (CRFs) Clinical AM2 CRF Packet Clinical AM3 CRF Packet Clinical AM4 CRF Packet |
The forms that were used to collect information about specific assessments and other variables, and a guide to how those forms are completed. This packet of CRFs may not represent all data points collected at a given visit. For an understanding of other versions of the forms review the archived versions linked here. | Archive |
Operations Manuals and Specimen Processing Maps
Step-by-step detail of the sample collection processes to guide PPMI cores and clinical sites in following the study protocol.
Category | Primary content | Notes | Archive/ prior version |
|---|---|---|---|
| General | Clinical Operations Manual | Archive | |
| Biologics | Biologics Manual | Details of acquisition procedures for blood, CSF, urine, and skin biopsies. | Archive |
| Pathology Manual | Details of brain donation, collection, analysis, and storage managed by PPMI Pathology Core. | Prior version | |
| Genetics | Genetics Manual | Details of genetic processing. | |
| Specimens | Cell Lines Manual of Procedures | Archive | |
| Biospecimen Processing Map Manual | Archive | ||
| Imaging (Molecular and Structural) | MRI MRI TOM Final v3.0 MRI TOM Final v4.0 | As some MRI imaging facilities do not have the technical capabilities to perform the DTI and rs-fMRI acquisitions included in the updated MRI TOM v4.0, they are performing scanning with the previous version of the MRI TOM (v3.0). | Archive |
| DTI | Current DTI Acquisition protocol. | ||
| SPECT | Dopamine transporter SPECT protocol. | Archive |
Other PPMI Program Protocols
Primary content | Notes | Archive/prior version |
|---|---|---|
| PPMI Online Protocol | PPMI Online is a longitudinal study of patient reported outcomes (PROs) administered online, including people with and without PD. This document provides an overview of the PPMI Online study. How to cite: Caroline M Tanner, Ken Marek 2024. Parkinson’s Progression Markers Initiative Online Study (PPMI Online). protocols.io https://dx.doi.org/10.17504/protocols.io.q26g718y9gwz/v1 | |
| PPMI Online Schedule of Activities | The frequency of study visits and what assessment occurs at each visit for PPMI Online. | Archive |
| PPMI Online Participant Reported Outcomes (PROs) |
Data and Biospecimen Use Agreements and Policies
Primary content | Notes | Archive/ prior version |
|---|---|---|
| Data Use Agreement | Archive | |
| Biospecimen Use Agreement | Archive | |
| Publications Policy | Archive | |
| Cell Line Agreement | Archive | |
| Cell Lines Material Transfer Agreement | Archive |
Sub Studies
For documents related to sub studies, go to the
Sub Studies page.