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Hot Flashes Study Sections
 Author Bio
Introduction 
Commentator Bio
Protocol Schema
Protocol Background
Protocol Goals
Patient Eligibility
Test Schedule
Stratification Factors
Registration/Randomization
Protocol Treatment
Dosage Modification
Ancillary Treatment
Currently selected section: Toxicity Monitoring
Treatment Evaluation
Descriptive Factors
Treatment/Follow-up
Pharmacologic Studies
Drug Information
Statistical Considerations
Pathology Considerations
Records/Data Collection Procedures
Budget
Appendices

 

Chapter 2B: Development of a Clinical Trial for Hot Flash Protocol: Toxicity Monitoring and Adverse Reaction Reporting
 

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10.1 Reporting for Commercial Medications:

ADR reporting is based on the Common Toxicity Criteria (Appendix II). Adverse reactions requiring submission to NCCTG Operations Office must also be reported to the local IRB.

 

                                               
Unexpected grade 4 - 5
Increased incidence of a known ADR 1
FDA Form 3500 to
NCCTG within 5 days 2
X
X

 

  1. Any increased incidence of a known ADR that has been reported in the package insert or the literature, including adverse event resulting from a medication overdose.

  2. Fax or mail:

NCCTG Operations Office
200 First Street, SW
Rochester, MN 55905
Fax: 555-555-5555

10.2 Toxicities to be graded at each evaluation and pretreatment symptoms/conditions to be evaluated at baseline per NCI CTC grading (Appendix II) unless otherwise stated: None.


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