Protocol: Protocol

Vendor: Vendor
Version: v2 14-FEB-2022
Date Received by PCMT: Date

File naming convention: Protocol_Vendor_VAR_v2 14-FEB-2022_Date

CTTS Setup instructions (for PCMT, not the Vendor):

Enter Sites in CTTS.
Ensure that CMRNs are on the PCMT Team and attached to Sites in CTTS.

Process:
1. Vendor adds rows to the sheets. This workbook is an ongoing history of changes.
2. Vendor emails this workbook to the PCM Trials Project Manager (PM).
3. PCM Trials PM quality-checks the workbook.
4. PCM Trials team updates CTTS. (If there are 50 or more records for any one CTTS record type, consider preparing a bulk upload [refer to job aids].)
5. PCM Trials CPC saves the VAR under the Project Folder in SharePoint.
Vendor: Vendor Protocol: Protocol

Entry Date Site ID Country Site Contact Date Site Training Date Comments

03-Oct-2022 401 Brazil 26-Sep-22 28-Sep-22

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Vendor: Vendor Protocol: Protocol

Entry Date Name Role Team Roll On Date Team Roll Off Date QuickSTAT access? Country Country Roll On Date Country Roll Off Date Comments

06-Mar-2023 PAULO SERGIO QUEVEDO PERES CMRN 01-Mar-2023 No BRAZIL

16-Mar-2023 FRANCIELE NATALIE TORRES CMRN 16-Mar-2023 No BRAZIL
23-Mar-2023 LUCAS JACQUES SANCHES AQUINO CMRN 20-Mar-2023 No BRAZIL

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Vendor: Vendor Protocol: Protocol

Date Regulatory Regulatory

Date Regulatory
Documents Quality Documents Quality
Entry Date CMRN Visit Training Version CMRN CMRN Country Trainer Training Delivery Date Site ID Checked Prior to Checked By (Local Documents Sent to
Sending to Site CC): Site

06-Mar-2023 V1: 22-JUN-2022 PAULO SERGIO QUEVEDO PERES BRAZIL DIOGO LOPES 01-Mar-2023 401 06-Mar-2023 06-Mar-2023 06-Mar-2023
30-Mar-2023 FRANCIELE NATALIE TORRES BRAZIL DIOGO LOPES 27-Mar-2023 401 30-Mar-2023 30-Mar-2023 30-Mar-2023
30-Mar-2023 LUCAS JACQUES SANCHES AQUINO BRAZIL DIOGO LOPES 27-Mar-2023 401

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Vendor: Vendor Protocol: Protocol

State/Province Subject Referral Form Baseline/Anchor Date-

Entry Date Site ID Subject ID Country City Time Zone Primary CMRN
(Fully Spelled) Receipt Date Time

18-Jan-2023 401 401-059 Brazil Rio Grande do Sul Santa Maria BRT 17-Jan-2023 30-Jan-2023 00:00 PAULO SERGIO QUEVEDO PERES
18-Jan-2023 401 401-065 Brazil Rio Grande do Sul Palmeira das Missões BRT 17-Jan-2023 08-Feb-2023 00:00 PAULO SERGIO QUEVEDO PERES
18-Jan-2023 401 401-069 Brazil Mato Grosso do SuBonito (Rural area) BRT 17-Jan-2023 14-Mar-2023 00:00 LUCAS JACQUES SANCHES AQUINO
18-Jan-2023 401 401-075 Brazil Minas Gerais Belo Horizonte BRT 17-Jan-2023 03-Mar-2023 00:00 FRANCIELE NATALIE TORRES

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Vendor: Vendor Protocol: Protocol
Visit Completion ###
Visit Scheduling Travel Before Visit Travel After eRequisition Utilization
Physician Order Form (POF) Window Open Window Close Outcome? Was eRequisition Utilized Date-Time Source Paper Source Tracking
Entry Date Country Site ID Subject ID Receipt Date Visit ID Date Target Date Date CMRN (full name) Scheduled Date & Time Hours Minutes Distance Start Date & Time End Date & Time Hours Minutes Distance (Yes|No|n/a) If No, who/what failed? Comments emailed to Site Number

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