Basics of Data Collection Forms Training

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

3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078665/ 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 E6 1.11 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.” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf

5. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf What is a Source Document (SD)? “ICH E6 1.51 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 E6 1.52 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?

7. What is the Difference Between a Source Document and a Data Collection Form?

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. http://slideplayer.com/slide/3807175/ Examples of Source Documents • Medical History • Hospital Records • Clinic & Office Charts • Progress notes • Lab Notes • Memoranda • Meeting Minutes • Notes to File • Phone Records • Subject Diaries • Questionnaires • Subject files or records • Drug dispensing records • Recorded data from automated instruments (EKG, EEG, etc…) • X-rays, scans, MRIs • Video and Audio Recordings

11. http://slideplayer.com/slide/3807175/ 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. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf How Long Should DCFs and Source Documents be Stored According to GCP Guidelines “ICH E6 5.5.11 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. http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdfhttp://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf How Long Should DCFs and Source Documents be Stored According to TTUHSC El Paso HRPP Guidelines “HRPP 2.6.2 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 3.17.1 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 be used as data collection forms for source data • To ensure that only data required by the protocol is being collected • 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: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf • GCP ICH E6 Guidelines Questions: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoInquiriestoFDAonGoodClinicalPractice/default.htm • Datmouth-Hitchcock: http://med.dartmouth-hitchcock.org/clinical_trials/source_documents.html • Cochrane.org: http://handbook.cochrane.org/chapter_7/7_5_3_design_of_a_data_collection_form.htm • SlidePlayer: http://slideplayer.com/slide/3807175/ • TTUHSC El Paso HRPP Manual: http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf • Source Documents and Case Report Forms: Forms and Function: http://www.idcrp.org/sites/default/files/IDCRP%20Brown%20Bag%20Presentation_CRF_26Feb2015.pdf

21. Questions?