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Computer Assisted Self Interview (CASI) Donor Questionnaires. Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009. Outline. CASI Software Applications Overview Web-based systems Non-web-based systems SOP content Submissions: Information to include

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computer assisted self interview casi donor questionnaires

Computer Assisted Self Interview (CASI) Donor Questionnaires

Michael Gorman, BA, MT(ASCP)SBB

Consumer Safety Officer, CBER, OBRR, DBA

September 15, 2009

outline
Outline
  • CASI Software Applications Overview
    • Web-based systems
    • Non-web-based systems
  • SOP content
  • Submissions: Information to include
  • Submissions: Documents to include
  • Submissions: Print Screens
  • Submissions: Reporting categories
  • References
casi software applications overview
CASI Software Applications Overview
  • Donors review questions via a computer and respond electronically
    • Medical/health history questions
    • High-risk behavior questions
  • Non-web-based Applications:
  • Accessed on-site (fixed locations & mobiles)
  • Web-based Applications:
  • Remote donor access via the Internet
sop content web based non web based casi
SOP Content: Web-based & Non-web-based CASI
  • Steps describing the self-administered questionnaire process including use of the software program [21 CFR 606.100(b)]
  • Donor must complete questionnaire on the day of donation [21 CFR 640.3]
    • Web-based: How to determine if questionnaire was completed on day of donation
    • Web-based: What actions to take if donor appears the day after
sop content web based non web based casi cont
SOP Content: Web-based & Non-web-based CASI(cont.)
  • Non-web-based: Describe how donor privacy is assured at fixed locations and mobile sites, when applicable [21 CFR 606.40(a)(1)]
  • Web-based: Describe steps for determining if questionnaire was completed in a private setting [21 CFR 606.40(a)(1)]
sop content web based non web based casi cont6
SOP Content:Web-based & Non-web-based CASI (cont.)

Additionally we recommend you include:

  • How donor comprehension of questions is assessed and documented
  • Alternate procedures if computer system is unavailable
  • Alternative methods for donor screening
    • Donor does not wish to use CASI
    • Donor unable to use CASI
sop content web based non web based casi cont7
SOP Content:Web-based & Non-web-based CASI (cont.)
  • Additionally we recommend you include (cont.):
  • Availability of staff to respond to a user’s questions
  • How changes to donor responses or interviewer’s comments are documented
  • How questionnaire revisions are managed
    • Revisions should be made obvious to donors in some manner for at least one year
additional sop content web based casi
Additional SOP Content: Web-based CASI
  • How donor identity is confirmed upon arrival at center [21 CFR 640.3]
  • How donor responses are documented when donor is at the center (electronic or hard copy) [21 CFR 606.160]
submission information to include
Submission: Information to Include
  • Software manufacturer’s name
  • Software name
  • Software version or release number
  • Software capabilities and functions
  • 510(k) number
  • Who can modify the software
submission information to include cont
Submission: Information to Include (cont.)
  • Usage on mobile operations, if applicable
  • CASI wireless connectivity on mobile operations, if applicable
    • Is wireless functionality 510(k) cleared?
  • Software interfaces with other regulated devices such as BECS, if applicable
  • List of fixed locations with addresses where software will be used/installed
submission information to include cont12
Submission: Information to Include (cont.)
  • Does system interface with other locations where program is installed or is it stand-alone (independent)
  • Who can modify the donor health history questionnaire (DHQ)
  • Are medical history and/or AIDS high risk questions computer administered
submission information to include cont13
Submission: Information to Include (cont.)
  • Are donor suitability decisions made by the software and/or center personnel
submission additional information typically requested
Submission: Additional Information Typically Requested
  • Who is authorized to access the system and enter or change data
    • Example: changing software applied donor suitability decisions, if applicable
  • How system access is managed
    • Authorization and deauthorization
submission documents to include
Submission: Documents to Include
  • SOPs
  • Donor instructions for completing the questionnaire
  • Copy of DHQ
  • Validation protocol
    • Pre-defined written plan that was used for on-site validation prior to implementation
    • Do not include actual validation data
  • Print screens
submission documents to include print screens
Submission: Documents to Include Print Screens

All print screens

  • New non-web-based CASI
  • New DHQ used with CASI not previously:
    • Approved by FDA, or
    • Accepted by FDA in a guidance document
  • New web-based CASI: non-web-based CASI not previously approved
submission documents to include print screens cont
Submission: Documents to Include Print Screens (cont.)

Only print screens for web-based CASI

  • New web-based CASI: non-web-based CASI previously approved
submission reporting categories
Submission Reporting Categories
  • CBE-30 – Web-based CASI if already approved for non-web-based CASI
  • CBE-30 – CASI or web-based CASI – firm’s DHQ previously approved by FDA
  • CBE-30 – CASI or web-based CASI- DHQ has been accepted by FDA in a guidance document
  • PAS – CASI or web-based CASI - new DHQnot previously approved or accepted by FDA
references
References
  • 21 CFR 601.12
  • Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires (7/3/2003)
  • Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components  (10/27/2006) 
references cont
References (cont.)
  • Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (8/07/2001)
  • Guidance Link: FDA website A to Z Subject Index - G Page; Click Guidance Documents – Biologics: http://www.fda.gov/SiteIndex/ucm148505.htm
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