Download Source Data Location List

Source Data Location List
Study title & Acronym
page _____ of _____
Study Site:
Local Principal Investigator:
This list specifies the location of all source data items. It should be updated as necessary. The list may be used to specify which data can be entered
directly into the (e)CRF as source:
<Adapt red text as needed>
Source Data Type
Location source data
Dated statement that the subject entered the clinical study (e.g. “patient enrolled in
study XXX”)
Patient record
Statement to confirm that subject has signed the informed consent form (including
the version signed) and that subject has received a copy of the patient information
and informed consent form
Patient record
Visit dates
Patient record
Diagnoses made (incl. confirmation of disease/ condition being treated)
Patient record
Concomitant medication
Patient record
Serious adverse events
Patient record
Completed informed consent form
Patient record (copy)/ investigator site file
Medical History
Patient record
Demographics
Patient record (or eCRF)
Weight
Patient record – nurses notes
Inclusion/ Exclusion Criteria
Inclusion/ Exclusion criteria list filed in patient records
Pregnancy Test (if applicable)
Lab report filed in patient record
Study Drug Administration
Dispensing and administration chart, patient record
Lab Safety Data
Lab reports filed in patient record
Vital Signs
Patient record – nurses notes
12-lead ECG
Print-out filed in patient record
<Study Acronym>, Source Data Location List
Source Data Location List
Study title & Acronym
page _____ of _____
Study Site:
Local Principal Investigator:
Source Data Type
Location source data
SAEs/ Pregnancy Notification
Investigator site file
X-ray/ image scans
Electronic patient record
Automated instrument printouts
Patient record
Study termination date/ Participant withdrawal date
Patient record
Continue/ delete/ change items as needed
Current version and date of list:
________________________________
Date of signature:
________________________________
Signature of principal investigator or delegate:
________________________________
<Study Acronym>, Source Data Location List