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. | Archive |
| Schedule of activities (SOAs) | 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 |
| Case report forms (CRFs) | 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 | Operations Manual | Prior version - May 2021 Prior version - Jan 2021 | |
| 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 | ||
| Biospecimen Processing Map Manual | Archive | ||
| Imaging (Molecular and Structural) | MRI | Current MRI Acquisition protocol. | Prior version - August 2020 Prior version - Jan 2015 |
| DTI | Current DTI Acquisition protocol. | ||
| SPECT | Dopamine transporter SPECT protocol. Independent Review Charter can be found here. | Archive |
Other PPMI Program Protocols
Primary content | Notes |
|---|---|
| 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. |
| PPMI Online Schedule of Activities | The frequency of study visits and what assessment occurs at each visit for PPMI Online. |
| 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.