Research Documents & SOPs

Study Documentation

Primary content
Notes
Archive/
prior version
Clinical protocol currentThis 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)

Healthy Control SOA Year 0-5 (AM 3.2)
Healthy Control SOA Year 6+ (AM 3.2)
Prodromal SOA Year 0-5 (AM 3.2)
Prodromal SOA Year 6+ (AM 3.2)
PD SOA Year 0-5 (AM 3.2)
PD SOA Year 6+ (AM 3.2)

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)

Clinical AM2 CRF Packet
Clinical AM3 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
GeneralOperations Manual Prior version - Feb 2023
Prior version - May 2021
Prior version - Jan 2021
BiologicsBiologics ManualDetails of acquisition procedures for blood, CSF, urine, and skin biopsies.Archive
Pathology ManualDetails of brain donation, collection, analysis, and storage managed by PPMI Pathology Core.Prior version
GeneticsGenetics ManualDetails of genetic processing. 
SpecimensCell Lines Manual of ProceduresArchive
Biospecimen Processing Map ManualArchive
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
DTICurrent DTI Acquisition protocol. 
SPECTDopamine transporter SPECT protocol.Archive

Other PPMI Program Protocols

Primary content
Notes
Archive/prior version
PPMI Online ProtocolPPMI 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 ActivitiesThe 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

Sub Studies

For documents related to sub studies, go to the Sub Studies page.