2. Reviewing eCRFs

Reviewing eCRFs prior to releasing the calendar and the forms is a very important step in ensuring your study team has the tools it needs to track subject data for your protocol. When you are asked to review the eCRFs as a study coordinator, you are being asked to make sure they work as expected, they capture the data that has been identified by the Protocol Development team and the Biostatistician as important for the study analysis, and that the fields available are in an accurate format to capture that data. 

Questions to Ask While Reviewing

1. Does the study calendar match the data submission schedule found in the protocol?
2. Will the forms, as written, collect all relevant data in order to meet the study objectives?
3. Are the forms listed under each event correct for that event/time point?
4. Do the permissible values for each variable make sense?
5. Is each variable coded appropriately?
1. Do the questions that have multiple answers allow for multiple selections?
2. Do variables that can occur an indeterminate amount of times per form have the ability to add more?
3. Do the free text variables allow for enough characters?
6. Are ranges set correctly for numeric-text fields when applicable?
7. Do variables that may require an "Other-Specify" option contain one that provides a free-text field to specify?
8. Is everything spelled correctly?
9. Do the log sections (sections where more than one event will be added to a list) of a form allow entry and saving of multiple rows of data?

Steps for Study Team Review

1. Look at each individual form:
1. Do the values match the information that will be available for subjects?
2. Does the association of the forms with specific visits in the calendar make sense based on when that information will be collected/available for each subject?
3. Are the fields in the correct format for data entry?
2. Verify Calendar triggers visits appropriately
1. eCRFs/Specifications Menu > Calendars > Protocol Number > Preview Calendar button will be in the top right corner of the protocol calendar
1. Enter the dates in the pop-up window to correspond with dates a subject may Sign Consent, go On Study and On Treatment, come Off Treatment, and go On Follow Up
2. A planned visit calendar will result with projected dates for all visits based on your input
2. eCRFs/Specifications Menu > Calendars > Protocol Number > Treatment Visits tab on the left hand side will show you which calendar segments are tied to which Subject Status dates
3. If something is not triggering the way you expect or believe it should, please reach out to the OST with specifics
3. Add 2-4 "Test" Subjects to the Test Protocol
1. Please make sure you contact the OST to verify which subjects are actual Test subjects so we don't put a real patient on a Test Protocol by mistake if there are not already test subjects added to your protocol
4. Place Test Subjects On Study and On Treatment.
5. Enter Visit data for all Test Subjects
1. For each Test Subject, create a unique treatment path to ensure all forms and visits occur appropriately in different scenarios
1. One subject should complete all treatment visits as planned and complete Follow Up Visits as planned
2. One subject should miss multiple visits
3. One subject should go off study early due to disease progression
4. One subject should go off study early due to Toxicity
2. Make sure you complete each set of Visit's forms as you mark that visit as "Occurred"
1. Do not mark multiple visits as "Occurred" all at once and then go and try to enter data into all the forms at once
2. The process for checking in visits and completing forms is as follows:
1. Mark single subject visit as occurred
2. Navigate to Subject's To Do Forms
3. Enter Data on Forms and Save
4. Complete Forms
5. Return to subject's calendar and repeat Steps 1-4
3. After you enter the data on a form, make sure you "Save" and "Mark As Complete"
1. Ensure that the form's status updates based on these actions
4. Ensure all forms function as expected and all data is retained as expected
5. Make sure to fill out each form more than 1 time to ensure proper utility
1. This can mean filling it out at more than one visit for the same patient or filling it out for multiple patients