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.................................................................4  \nMedical Monitor Contact .......................................................................5  \nPPMI Study Core Primary Personnel ......................................................6  \nStudy Personnel .....................................................................................9  \nIND SMC Office Closings .......................................................................10  \n2.0 OBTAINING INFORMED CONSENT ......................................................... 11  \nAll PPMI Participants ............................................................................11  \nDesignation of Research Proxy.............................................................11  \nGDPR Addendum..................................................................................11  \n3.0 ENROLLMENT ........................................................................................ 11  \nParticipant Profile Information ............................................................11  \nActivities Prior to Enrollment ...............................................................12  \nProtocol Deviations ..............................................................................13  \nProtocol Waivers ..................................................................................13  \n4.0 IMAGING ............................................................................................... 14  \nOrdering DaTscan™ (US Sites) ..............................................................14  \nOrder Cancellation (US Sites) ...............................................................14  \nShipment to Sites (US Sites) .................................................................15  \nOrdering DaTscan™ (EU/Israel Sites) ....................................................15  \nStorage of DaTscan™ ............................................................................15  \nAdministration of DaTscan™ ................................................................16  \nAccountability of DaTscan™ .................................................................16  \n99mTc-TRODAT-1 (Lagos only) ...............................................................16  \n5.0 SOURCE DOCUMENTATION................................................................... 16  \nTypes of Visits ......................................................................................17  \nAssessment and Study Supply Ordering ...............................................17  \n6.0 SIGNIFICANT STUDY EVENTS ................................................................. 18  \nInitiation of PD Medication ..................................................................18  \nAdverse Event Reporting ......................................................................18  \nSerious Adverse Event Reporting-PPMI002 Clinical Protocol ...............18  \n7.0 LABORATORY SPECIMEN MANAGEMENT ............................................. 20  \nPregnancy Test Kits ..............................................................................20  \n8.0 SITE MANAGEMENT .............................................................................. 20  \nSite Activation Process .........................................................................21  \n9.0 ESSENTIAL DOCUMENTS & ELECTRONIC TRIAL MASTER FILE (eTMF) SYSTEM………………………………………………………………………………………………………………………………22  \nEssential Documents ............................................................................22  \neTMF System ........................................................................................28  \nParticipant Transfer Process ................................................................28  \nTable of Documents ............................................................","cbCaiffyUO8NWXDf","https://ap.wps.com/l/cbCaiffyUO8NWXDf","pdf",795780,"English","# General Information\n## Study Management Contacts\n## Medical Monitor Contact\n## PPMI Study Core Primary Personnel\n## Study Personnel\n## IND SMC Office Closings\n# Obtaining Informed Consent\n## All PPMI Participants\n## Designation of Research Proxy\n## GDPR Addendum\n# Enrollment\n## Participant Profile Information\n## Activities Prior to Enrollment\n## Protocol Deviations\n## Protocol Waivers\n# Imaging\n## Ordering DaTscan (US Sites)\n## Order Cancellation (US Sites)\n## Shipment to Sites (US Sites)\n## Ordering DaTscan (EU/Israel Sites)\n## Storage of DaTscan\n## Administration of DaTscan\n## Accountability of DaTscan\n## 99mTc-TRODAT-1 (Lagos only)\n# Source Documentation\n## Types of Visits\n## Assessment and Study Supply Ordering\n# Significant Study Events\n## Initiation of PD Medication\n## Adverse Event Reporting\n## Serious Adverse Event Reporting\n# Laboratory Specimen Management\n## Pregnancy Test Kits\n# Site Management\n## Site Activation Process\n# Essential Documents & eTMF System\n## Essential Documents\n## eTMF System\n## Participant Transfer Process\n## Table of Documents\n# Appendices\n## Exclusionary Medications\n## Exclusionary Conditions\n## Medications to Hold for DaTscan\n## Previously Acquired DaTscan Request Form\n## Lost to Follow Up Guidance\n## Out of Clinic Visit Guidance","[{\"question\":\"What topics does the manual cover for running the PPMI study day to day?\",\"answer\":\"It covers core operational areas including informed consent, enrollment, protocol deviations and waivers, imaging workflow, source documentation, significant study events, specimen management, and site management activities.\"},{\"question\":\"How are DaTscan processes addressed across different site regions?\",\"answer\":\"The manual specifies DaTscan ordering, cancellation, shipment, storage, administration, and accountability, including separate guidance for US sites versus EU/Israel sites and additional handling such as 99mTc-TRODAT-1 for Lagos.\"},{\"question\":\"What systems and 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