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General Instructions for CRF 3 Rev H To be completed at each follow up visit

General Instructions for CRF 3 Rev H To be completed at each follow up visit. Verify CRF is Rev H. Patient Identification and Group. Date of Visit. If mammogram not performed DO NOT complete this section. Assessment performed physician by. IMPORTANT OUTCOME MEASURE.

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General Instructions for CRF 3 Rev H To be completed at each follow up visit

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  1. General Instructions for CRF 3 Rev H To be completed at each follow up visit Verify CRF is Rev H Patient Identification and Group Date of Visit If mammogram not performed DO NOT complete this section. Assessment performed physician by. IMPORTANT OUTCOME MEASURE If change from previous visit, specify why Disease free? Recurrence? IMPORTANT OUTCOME MEASURE Provide start and stop date of adjuvant therapy. This should be completed at each visit until patient no longer receiving adjuvant therapy. Survival Status Radiation Recall Reaction: May occur following chemotherapy in the absence of additional radiation therapy. Attempt to contact patient at least 3x prior to entering as Lost to F/U. Date of Mammogram

  2. General Instructions for CRF 4 – Adverse Events To be completed at each follow up visit Is the event under observation? Not resolved? Provide start and stop date Patient Identification and Group Adverse Event? YES or NO Date of Visit Is event ongoing from last visit? Not a new event? See Definitions CRF 4, pg 2 Describe all adverse events using medical terminology, ie, desquamation, pain in breast, drainage, etc. using definitions provided for in coding. Intervention: Be specific Other Events Adverse Event Example: New event of breast pain occurs on 6/4/04. A start date will be entered but if it is not resolved, it will be checked as Under Observation. Is this a Serious AE? Death or threat to life, permanent impairment, requires medical or surgical Intervention to preclude permanent impairment Adverse Event Example:Erythema starts on 5/6/04 and is still present at next visit. You will list it again and check ongoing. You do not need to repeat the start date as the event is ongoing.

  3. Adverse Event Definitions To be used as a guide to completing CRF 4, Page 1

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