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

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 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078665/

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

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).” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf

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

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

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

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

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 http://slideplayer.com/slide/3807175/

What a Source Document may Look Like… http://slideplayer.com/slide/3807175/

What a DCF may Look Like…

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

Some Key Points to Remember When Creating a DCF

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

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.” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.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.” http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf

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

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

Resources GCP ICH E6 Guidelines: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gu idances/ucm073122.pdf GCP ICH E6 Guidelines Questions: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoI nquiriestoFDAonGoodClinicalPractice/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.h tm 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

Questions?