EDC Draft
In reviewing the study protocol, the goal of the clinical data manager is to
determine:
1) What Visits/Folders should be in the EDC?
2) What CRFs should be in the EDC?
3) How the CRFs should be arranged in Folders?
4) What fields will be in the CRFs?
1 ) What visits/folders should be in the EDC? Refer to the Schedule of
Events on the Protocol
Visits
Screening/Enrollment
Pre-NeoAdjuvant
Pre-Surgery/Surgery
Post-Surgery/Pre-Treatment
Tumor Tissue Sample
6-Week Visit 1 TO 108-Week Visit 18
End of Study
Unscheduled Visit
2) What CRFs should be in the EDC? Refer to the Schedule of Events on
the Protocol
Visit
Eligibility Criteria
Informed Consent
Demographics
Medical History
Current Cancer History
Second Primary Cancer History
Disease Status
Tumor Tissue Collection
Blood Collection
Imaging
Pathology
Tumor Markers
End of Study
Prior and Concomitant Therapies
Prior and Concomitant Medications
Adverse Events
Protocol Deviations
3) How the CRFs should be arranged in Folders? Refer to the Schedule of
Assessments
Screening Visit
Visit
Eligibility Criteria
Informed Consent
Demographics
Medical History
Current Cancer History
Second Primary Cancer History
Blood Collection
Imaging
Pathology
Tumor Markers
Pre-Neoadjuvant
Visit
Second Primary Cancer History
Blood Collection
Imaging
Pathology
Tumor Markers
Pre-Surgery/Surgery
Visit
Second Primary Cancer History
Blood Collection
Imaging
Pathology
Tumor Markers
Post-Surgery/Pre-Treatment
Visit
Second Primary Cancer History
Disease status
Blood collection
Imaging
Pathology
Tumor markers
Tumor Tissue Sample
Tumor Tissue Collection
6-Week Visit 1
Visit
Second Primary Cancer History
Disease status
Blood collection
Imaging
Pathology
Tumor markers
What fields will be in the CRFs? Refer to The Protocol (Study
Procedures, Schedule of Events Footnotes, The Entire Protocol), aCRFs
from other Studies and CDASH (Clinical Data Acquisition Standards
Harmonisation). CDASH is a standard for CRFs, created by CDISC
(Clinical Data Interchange Standards Consortium)
VISIT
Visit Completed Yes/No. Radio Button
Visit Date Calendar
If visit not completed, reason Drop Down: Unable to schedule the Visit
Physician Decision
Other
Other Specify Free text
Demographics
What is the sex Dropdown:Female
of the subject? Male
Unknown
Undifferentiated
Gender Radio Button: Female/Male
Sexual Drop Down: https://www.bing.com/search?
Orientation q=Bisexuality&FORM=SNAPST&filters=sid:
%222849e76d-cc06-a41d-d1e3-
4a2770519791%22+fcid:%22GeneratedCarousel-
97b56185-14f3-741b-1211-3d1ff54245e9%22
What is the Calendar
subject’s date
of birth?
What is the Text Box
subject’s age at
enrolment
Do you consider DropDown: Hispanic or Latino
yourself Not Hispanic or Latino
Hispanic/Latino Not Reported
or not Unknown
Hispanic/Latino?
Which of the Checkbox: American Indian or Alska Native
following five Asian
racial Black or African American
designations Native Hawaiaan or other Pacific Islander
best describes White
you? (More than
one choice is
acceptable.)
I request the study team to help with these demographic fields as
requested in the protocol: Country of birth and location history,
Geography: zip code, county (for categorization of rurality such as
rural-urban continuum codes / rural-urban commuting area
[RUCC/RUCA] codes and / or socioeconomic area level measure),
Socioeconomic information, including but not limited to:
Self-reported income and education level
○ Insurance status
Were any adverse effects Dropdown: Yes
experienced? No
Adverse Event Category
Adverse Event Sub
Category
What is the Adverse Event
Term?
Start Date Calendar
Is the Adverse Event Dropdown : Yes
ongoing? No
End Date Calendar
What is the severity of the Dropdown: Mild
Adverse Event Moderate
Severe
Was the Adverse Event Dropdown: Yes
serious? No
Was the Adverse Event Dropdown : Yes
associated with congenital No
anomaly or birth defect?
Did the Adverse Event Dropdown : Yes
result in disability or No
permanent damage?
Did the Adverse Effect Dropdown : Yes
result in death? No
Death date Calendar
Did the Adverse Effect Dropdown : Yes
result in initial or No
prolonged hospitalization
of the subject?
Was the Adverse Effect life Dropdown : Yes
threatening? No
Did the Adeverse Effect Dropdown : Yes
require intervention to No
prevent permanent
impairment or damage
due to the use of a
medical device?
Was the Adverse Event a Dropdown : Yes
medically important event No
not covered by other
serious criteria?
Action taken with study Dropdown: Drug Withdrawn
treatment Dose Reduced
Dose Increased
Dose not changed
Unknown
Not Applicable
Relationship to study Dropdown: Not Related
treatment Unlikely Related
Possibly Related
Related
Outcome Dropdown: Recovering
Not Recovered
Recovered
Recovered with Sequelae
Fatal
