Hy uspasien chinicaL SURE-PD3 (2 Reseancn Site Activation Checklist and Approval Form PaTnOre i ‘Carmen Serrano Ramos, Site Name: University of Puerto Rico __| Site PI Name: MD PSG Site #: 068 NCRI Action Date: | 19 December 2016 NCRI-Approved Study Team: __| Carmen Serrano Ramos, MD; Francisco Muriel (Staff not listed above are not approved to participate on the SURE-PDS study team until NCRI approval & granted) TIER 2: NCRI Approval for Site Activation - Open Enrollment 1 ‘CRI Tier 1 Approval 2. EQ) Regulatory Documents Completed for All Essential Study Staff i. Includes Completion of All Post-Investigators’ Meeting Training Requirements 4, DEL Log start date should be the day you complete all trainings (including Outcomes Training and Study Start Up Training). (“People tnt attended the IM do not seed Jo complete the Study Start Up Log--> But they do need to complete the Outcomes Log) 3. Certificate of Confidentiality Assurances Signed and Uploaded 4. EX) Site Registered on Fox Trial Finder 5. Confirmation of site contact information on clinicaltrials. gov 6. Receipt of Supplies: Subject Binders, hardcopy (MMSE) & Subject Debit Cards 7 (IND Daf scan Center Approval to Scan 8. KK] Test ECG Received by ERT 9. EJ Receipt of Lab Supplies 10.) Receipt of Study Drug (or NCRI-confirmed expectation of receipt within 4 weeks) CCC PM Team has confirmed that Site PI is not on the FDA debarment list. TO) Approved By: a pate IV DEC Bat, Foe Mags Shae Neurologieal Clinical Resea’¢h in Site Activation Checklist and Approval Form ‘V3.0 (07}ul2016) Protocol# INO-PD-P3-2014 Page 1 of 1