2. Basics of Building and Understanding Data Collection Forms
Training for Investigators and Research Personnel

3. What is a Data Collection Form (DCF)?
“Data collection for clinical research involves gathering variables relevant to research hypotheses. These variables (‘patient parameters,’ ‘data items,’ ‘data elements,’ or ‘questions’) are aggregated into data-collection forms (‘Case Report Forms’ or CRFs) for study implementation. ” Please note that the terms data collection forms and case report forms can be used interchangeably

4. What is a Case Report Form (CRF)?
“ICH E Case report form (CRF): A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.”

5. What is a Source Document (SD)?
“ICH E Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).” “ICH E Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).”

6. What is the Difference Between a Source Document and a Case Report Form?
Sponsored Studies
Source Documents (SD)
Case Report Forms (CRF)
SDs are never provided by the sponsor in sponsored studies
Blank paper CRFs may or may not be provided by the study sponsor or contract research organization (CRO)
SDs are normally transcribed onto eCRFs or CRFs provided by the sponsor
Electronic CRFs (eCRFs) are normally provided by the study sponsor or CRO with instructions (electronic data capture system)
SDs are usually not modeled after the CRF or eCRF provided by the sponsor
CRFs can be modeled after the eCRFs that a sponsor provides
SDs are always retained at the research site and are rarely submitted to a sponsor
The eCRF is typically submitted to the sponsor without the site being able to keep a copy of what is being submitted
CRFs/data collection forms (DCF) can be SDs (first point of entry) as long as the CRA and/or sponsor has approved this
CRFs created at a site should not be submitted to the sponsor (they are for site use onlu)
CRFs used as SDs should be signed and dated by the person completing the form
These forms should only capture data according to protocol specifications
SDs may or may not be DCFs
CRFs are DCFs
You are expected to collect SDs to support your findings for the data that you input into an eCRF or CRF
It is not a common practice to create a CRF in a sponsored study, but it is something that is recommended to facilitate proper data capture for required protocol elements and to maintain a copy of the information submitted to a sponsor

7. Investigator-Initiated Studies
What is the Difference Between a Source Document and a Data Collection Form?
Investigator-Initiated Studies
Source Documents (SD)
Data Collection Forms (DCF)
Research personnel can create a DCF to use as a source document (first point of entry)
Data from source can be transcribed onto RedCap or some other electronic data capture system as long as it is approved through iRIS
Although the PI oversees all aspects of the study, they would not need to review SD in the same way that DCFs are reviewed and approved for use
If DCFs are created, the PI must review the CRFs before they are put into use
Depending on what is used as source, PHI might be listed on SDs (ex: physician notes from EMR, CT scans, etc…)
DCFs should not contain PHI
SDs should always be retained at the site
DCFs should always be retained at the site
SDs are not updated depending on protocol and study amendments (ex: physician notes from EMR, CT scans, etc…)
DCFs may need to be updated depending on protocol and study amendments
SDs should only include necessary information according to the protocol specifications
DCFs should be created so that they are purely based on the protocol specifications
DCFs used as SDs should be signed and dated by the person completing the form
DCFs should contain a line where they can be initialed and dated unless they are being used as SDs. If they are being used as SDs then they should have a place to sign and date
SDs may or may not be DCFs
CRFs are DCFs
You are expected to collect SDs to support your findings for the data required by the protocol
It is more common to create a DCF in an investigator-initiated study to ensure that only data specified in the protocol is captured

8. What Needs to be Submitted to the IRB?
Blank questionnaires
Blank surveys
Blank subject diaries and calendars
Blank data collection forms (DCFs) that are created specifically for investigator initiated studies and chart reviews
Blank eCRFs created on RedCap

9. What Doesn’t Need to be Submitted to the IRB?
DCFs/CRFs that are modeled after eCRFs that are created for sponsored studies
CRFs/eCRFs provided by sponsored studies
Phone Note Templates
Research Note Templates
Standard Departmental Forms

10. Examples of Source Documents
Medical History
Subject Diaries
Hospital Records
Questionnaires
Clinic & Office Charts
Subject files or records
Progress notes
Drug dispensing records
Lab Notes
Recorded data from automated instruments (EKG, EEG, etc…)
Memoranda
Meeting Minutes
X-rays, scans, MRIs
Notes to File
Video and Audio Recordings
Phone Records

11. What a Source Document may Look Like…

12. What a DCF may Look Like…

13. Some Key Points to Remember When Creating a DCF
The DCF should have a title
The DCF should include the protocol ID number
The DCF should include a revision/creation date, version number, and may include initials of person who revised/created form
You may add page numbers to make it easier to identify how many forms are in a set
There should be a blank space to include a unique subject identifier
There should be a space for staff completing the form to sign and date
A comment section may be useful at the end of the form

14. Some Key Points to Remember When Creating a DCF

15. Information That Should not be on a DCF
Patient PHI
Patient name
Medical records number
Patient social security number
Patient’s address
Patient’s contact information
Data or information that has not been approved for collection by the IRB

16. How Long Should DCFs and Source Documents be Stored According to GCP Guidelines
“ICH E The sponsor-specific essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period, however, if required by the applicable regulatory requirement(s) or if needed by the sponsor.”

17. How Long Should DCFs and Source Documents be Stored According to TTUHSC El Paso HRPP Guidelines
“HRPP Record Retention: The IRB Office shall retain IRB paper files for three (3) years after the final expiration date of the research study. Electronic files are maintained in iRIS for a minimum of three (3) years after final expiration date of the research study.” “HRPP Recordkeeping: All research records (including consent documents) must be kept for a minimum of three years after the close of the study at the local research site. Studies that involve drugs or devices seeking FDA approval must be kept for two years after the FDA has taken final action on the marketing application, or as directed by the Clinical Trial Agreement.”

18. Why are DCFs a Good Idea to Create and Maintain
For Sponsored Studies:
To be used as data collection forms for source data
To facilitate transcription process onto electronic sponsor CRFs
To ensure that only data required by the protocol is being collected
To maintain a record of what is being submitted to the sponsor at the site level
For Investigator Initiated Trials:
To abide by Good Clinical Practices in regards to maintaining accurate, complete, and verifiable recordkeeping

19. Summary CRFs are data collection forms
A source document is anything where data is directly captured and recorded
A DCF/CRF may or may not be source documents
DCFs and CRFs are protocol driven
Source documents, DCFs, and CRFs used as source documents must be maintained at TTUHSC El Paso site
DCFs may be useful in order to collect accurate information on a study per GCP guidelines

20. Resources
GCP ICH E6 Guidelines: idances/ucm pdf
GCP ICH E6 Guidelines Questions: nquiriestoFDAonGoodClinicalPractice/default.htm
Datmouth-Hitchcock: hitchcock.org/clinical_trials/source_documents.html
Cochrane.org: tm
SlidePlayer:
TTUHSC El Paso HRPP Manual:
Source Documents and Case Report Forms: Forms and Function:

21. Questions?