Medpass Request For Proposal Page 2
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4Request for Proposal
4. Study Document Preparation
Section Not Applicable
Responsibility
We are requesting that
Activity
Comments
MedPass:
MP
Sponsor
Develop
IB
Review and Comment
Develop
Protocol
Review and Comment
Develop
Sample Size Calculation / Estimation
Review and Comment
Develop
Statistical Analysis Plan
Review and Comment
Develop
Case Report Form
Review and Comment
Develop
Informed Consent Form
Review and Comment
Develop
Clinical Monitoring Plan
Review and Comment
Investigator Contract
Provide Template
Develop
Development of Other Study Documents
Review and Comment
(Randomization Instructions, SAE Reporting Guideline, etc.)
Development of Regulatory Binder Documents
(Device Accountability Log, Screening/Enrollment Log,
Personnel Signature Log, Site Visit Log, etc.)
Development of Regulatory Binders
Distribution of Regulatory Binder to Site(s)
Case Report Form Binder Printing
Management
5. Study Set-Up, Initiation, and Management
Section Not Applicable
Responsibility
Activity
Comments
MP
Sponsor
Trial Master File/Central File Set-Up & Maintenance
Site Identification
Site Qualification
Site Qualification / Pre-Study Phone Call(s)
EC Submission
CA Notification
Regulatory Document Collection
(CVs, Financial Disclosure Forms, EC Approval Documents, Informed
Consent Form, etc.)
Investigator Contract Negotiation
Investigator Meeting Preparation and Participation
Site Payment Management
Frequency of Payments:
Monitoring
Site Initiation Visit(s)
Interim Monitoring Visit(s)
Study Close-Out Visit(s)
6. Data Management
Section Not Applicable
Responsibility
Database Development Activities:
Comments
MP
Sponsor
Database Development and Validation
If MedPass to Develop & Validate Database:
MedPass Services RFP Form - October 2010
Page 2 of 5
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