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The initial DSM plan should include a brief description of data management methods, collection and reporting of Adverse Events (AE) and Serious Adverse Events (SAE), medical safety measures, communication plan with IRB/FDA/NIDA, interim analysis plans, and content and frequency of DSM reports to NIDA.

The Clinical Monitoring Plan (CMP) establishes the guidelines for conducting monitoring visits and related tasks for monitoring National Institute of Dental and Craniofacial Research (NIDCR) Protocol <protocol number, protocol title>.

A Monitoring Plan is a data collection plan for checking the ongoing health of the improved process. It lists the measure, the targets for each measure, how each measure will be checked, how and who will check the measures. It sets the stage for the Response Plan.

The purposes of clinical trial monitoring are to make sure that: The rights and well-being of human participants are protected. The reported trial data are accurate, complete, and verifiable from source documents (records of clinical findings, observations, or other activities in a clinical trial).

Areas of Focus Site assessment review and staff training (reference the Site Assessment Questionnaire). Human subjects protection. Protocol compliance. Regulatory compliance. Laboratory SOPs and compliance. Quality assurance. Adverse event reporting. Integrity of research data and samples.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232