Research Documents & SOPs

Study Documentation

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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)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.

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prior version
GeneralOperations Manual Prior version
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. 
GeneticsGenetics ManualDetails of genetic processing. 
SpecimensCell Lines Manual of Procedures 
Biospecimen Processing Map ManualArchive
Imaging (Molecular and Structural)MRICurrent MRI Acquisition protocol.Prior version - August 2020
Prior version - Jan 2015
DTICurrent DTI Acquisition protocol. 
SPECTDopamine transporter SPECT protocol. Independent Review Charter can be found here.Prior version - Oct 2020
Prior version - July 2020

Other PPMI Program Protocols

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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.

Data and Biospecimen Use Agreements and Policies

Sub Studies

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