Medpass Request For Proposal Page 3
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4Request for Proposal
6. Data Management
Section Not Applicable
Responsibility
Database Development Activities:
Comments
MP
Sponsor
Electronic Data Capture (EDC)
Yes
No
Programmed Study Progress Reports
Yes
No
Part 11 Compliance Required
Yes
No
Responsibility
Data Management Activities:
Comments
MP
Sponsor
Data Entry
Not Applicable – EDC Database
DCF / Query Management
7. Safety Surveillance and Reporting
Section Not Applicable
Responsibility
Activity
Comments
MP
Sponsor
SAE Regulatory Authority Reporting
SAE Tracking / Safety Event Management
CEC Member Identification
#
#
CEC Meeting Preparation
#
#
CEC Meeting Participation
#
#
DSMB Member Identification
#
#
DSMB Meeting Preparation
#
#
DSMB Meeting Participation
#
#
DSMB Statistical Report
8. Data Analysis and Clinical Report Generation
Section Not Applicable
Responsibility
Activity
Comments
MP
Sponsor
Interim Data Analysis
Reason for Analysis:
DSMB
Stop Trial
Other, Specify:
Number of Interim Analyses:
Interim Analysis and Clinical Study Report Activities:
Draft Template / Table Shells
Generate Tables / Analysis / Statistical Report
Write Interim Clinical Study Report
Interim Clinical Report Submission
Annual Report Activities:
Number of Annual Reports:
Draft Template / Table Shells
Generate / Populate Tables
Write Annual Report
Annual Clinical Report Submission
Final Analysis and Clinical Study Report Activities:
Draft Template / Table Shells
Generate Tables / Analysis / Statistical Report
Write Final Clinical Study Report
Final Clinical Report Submission
9. Regulatory Support
Section Not Applicable
MedPass Services RFP Form - October 2010
Page 3 of 5
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