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Demographic
Section
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Pretreatment
Section
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Eligibility Checklist | ||||||
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Registration/Randomization Forms |
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Confirmation of Registration | ||||||
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On Study Form | ||||||
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Pathology Transmittal Forms | ||||||
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All other required forms to be completed and/or submitted prior to initiating treatment | ||||||
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Treatment
Section (arranged by cycle)
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Treatment Form and/or Flow Sheet | ||||||
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List of Concomitant Medications | ||||||
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Adverse Event and Serious Adverse Event Reports | ||||||
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Lab Data | ||||||
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Tumor
Evaluation/Response to Treatment
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Radiology Forms/reports | ||||||
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Cytology Report | ||||||
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Pathology Results | ||||||
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Bone Marrow Aspiration Results | ||||||
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Serious
Adverse Effects
|
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Copy of Medwatch or AdEERS Report | ||||||
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Copy of supporting and followup documents | ||||||
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Off
Study
|
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Off Study Forms | ||||||
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Followup
Forms
|
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Follow-up forms (visit intervals defined in the protocol) | ||||||
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Correspondences relating to patient status (relapse, additional treatment, etc.) | ||||||
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Late Adverse Events or Secondary Malignancies Documentation | ||||||
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Death Form | ||||||
