Date complete history and physical performed:
Per protocol, a history and physical must be performed within 14 days prior to the start of conditioning. Enter the date the subject’s history and physical was performed in DD/MMM/YYYY format.
C-Reactive Protein test value:
Per protocol, a high-sensitivity serum C-Reactive Protein Test must be collected within 14 days prior to the start of conditioning. Report the most recent C-reactive protein test value prior to the start of the conditioning regimen in mg/L. Enter the value in “NN.N” format. This format allows for up to two digits prior to the decimal and up to one digit after the decimal.
Date C-Reactive Protein test completed:
Enter the date of the most recent C-reactive protein test prior to the start of the conditioning regimen in DD/MMM/YYYY format. Report the date of sample collection. If the conditioning regimen is delayed, the CRP and albumin will be retested if outside of the window.
Baseline PRO Survey
Has the baseline PRO survey been administered to the subject?
Report whether baseline PRO survey has been administered to the subject by a study team member. Indicate “Yes” if the baseline PRO survey was administered and continue with the following question. Indicate “No” if the baseline PRO survey was not administered and continue with question “if No, specify reason(s) not administered (check all that apply).” Note: if “no” is indicated, a Protocol Deviation eCRF must be completed.
If yes, what method for administering the survey was used?
Report what method was utilized to administer the baseline PRO survey. Indicate “Electronic Link” if the subject completed the survey online via a link provided by the site and continue with the following question. Indicate “Paper Survey” if the subject completed the survey on paper and continue with the question “Date paper baseline survey provided to subject.”
Date baseline survey electronic link provided to subject
Report the date the subject was provided with the electronic link to complete the baseline PRO survey in DD/MMM/YYYY format.
Date paper baseline survey provided to subject
Report the date the subject was provided a paper survey to complete in DD/MMM/YYYY format.
Date paper baseline survey completed by subject
Report the date the paper baseline survey was completed by the subject in DD/MMM/YYYY format. The date must be within the following window: Day -21 from conditioning start date to the conditioning start date.
If No, specify reason(s) not administered (Check all that apply)
If the baseline PRO survey has not been administered to the subject indicate the reason why it was not from the options listed below.
- Not within 21 days prior to conditioning
- Subject exited from study
- Other, specify (up to 200 characters)
Physician prognostication questionnaire
The Physician Prognostication questionnaire consists of 2 questions to be answered by the treating physician at baseline. Acceptable source document templates will be provided and include either:
- A paper source worksheet, with responses and signature by treating physician;
- Or email template, with reply from treating physician via email
Source document must be uploaded into Rave when complete (file format can be any of the following: xls, xlsx, pdf, doc, docx.)
Date provider completed physician prognostication questionnaire
Report the date the physician prognostication questionnaire was completed. Note, the physician prognostication questionnaire should be completed within 21 days prior to the conditioning start date. Please submit a protocol deviation if the physician prognostication questionnaire was not complete within window. Enter the date in DD/MMM/YYYY format.
For the type of transplant that has been chosen for your subject, what do you estimate survival at 1 year will be?
Per protocol, estimated survival at baseline must be determined by the patients treating physician. Indicate the patients estimated survival at 1 year based on the type of transplant chosen.
- Very good (more than 90%)
- Good (75-90%)
- Better than 50/50 (50-74%)
- Worse than 50/50 (25-49%)
- Bad (10-24%)
- Very bad (less than 10%)
Do you believe an individualized risk assessment tool that predicts 1 year non-relapse mortality based on the subject’s health and fitness would help you to make a recommendation to this subject about pursing transplant?
Indicate if an individualized risk assessment tool would help you to make a recommendation to this subject about pursuing transplant. Select from the following options:
- Yes, better predicting 1 year non-relapse mortality would help
- Yes, but only if the tool also predicts overall survival
- No
- Unknown/don’t want to answer
Physician survey source document (required):
Upload a copy of the physician survey source document listed above in one of the following formats: xls, xlsx, pdf, doc, or docx.
CCG v.4.0 | CRF v.3.0
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