Livinglinks is a specialized company servicing the needs of the Biotechnology, Pharmaceutical, and other technology companies located in and around the San Francisco Bay Area. Clinical data management with extensive experience in case report form design is our specialty. Our principal, Robert Shitamoto, has experience that spans over 16 years in the clinical research and the graphic design worlds as well as having a Genetics degree from UC Berkeley and a masters in public administration with a health care administration emphasis from CSU Hayward. We have designed case report forms for bay area biotech companies for over 7 years.

Our work within the Biotechnology and hi-tech industries has given us an excellent understanding of the growing design and data management needs of the industries. We are experienced in designing printed CRFs, PDF forms, eCRFs, and web forms. Our detail-orientation contributes to building quality data management tools where correct and complete data collection is critical. We perform other clinical data management tasks such as creating CRF completion guidelines (instructions) and annotated CRFs, performing UAT of eCRFs, writing specifications, evaluating EDC/CDMS vendors, planning, and project management. In addition to detailed and accurate CRF design where usability is essential we can design other forms for your specific business needs. Our hands-on, customer service attitude means that we take you through the step-by-step design process beginning with the initial design and finishing with the final custom designed piece.

 

Where the rubber meets the road...

Case Report Form (CRF) Design is the creation of questionnaires for use in clinical trial research. CRF Design falls under the regulated management of data collected from clinical research subjects involving issues of form design and usability, data entry, data quality, validity, accuracy, and privacy. CRFs may be designed for paper or electronic data collection.
Some printing vendors are The Strata Companies and Imperial Graphics.

One of the best open source Clinical Data Management Software (CDMS) platforms is OpenClinica www.openclinica.org by Akaza Research. OpenClinica meets the needs of academic health centers, clinical research cores, and individual investigators for Electronic Data Capture (EDC) and Clinical Data Management (CDM) in an affordable and easily extensible manner.

Standards such as CDISC www.cdisc.org and HL7 www.hl7.org are playing critical roles in the efficient collection and exchange of quality clinical data.

"The discipline of Clinical Data Management includes paper and electronic case report form (CRF) design, clinical trials database design and programming, data acquisition and entry into the clinical trials database, data review, validation, coding and database finalization. Independent of how individual companies perform these tasks within their company each company is obligated to ensure that the individuals performing these tasks follow Good Clinical Practices."
- Good Clinical Data Management Practices - SCDM www.scdm.org

Minimum Standards
• Design the CRF to collect the data specified by the protocol.
• Document the process for CRF design, development, approval and version control.
• Make the CRF available at the clinical site prior to enrollment of a subject.
• Document training of clinical site personnel on the protocol, CRF completion instructions and data submittal procedures prior to enrollment of a subject.

Best Practices
• Design the CRF along with protocol to assure collection of only these data the protocol specifies.
• Keep questions, prompts and instructions clear and concise.
• Design the CRF to follow the data flow from the perspective of the person completing it, taking into account the flow of study procedures and typical organization of data in a medical record.
• Avoid referential and redundant data points within the CRF whenever possible. If redundant data collection is used to assess data validity, the measurements should be obtained through independent means.
• Design the CRF with the primary safety and efficacy endpoints in mind as the main goal of data collection.
• Establish and maintain a library of standard forms.
• Make the CRF available for review at the clinical site prior to approval.
• Use NCR paper or other means to assure exact replicas of paper collection tools.

Recommended Standard Operating Procedures
• CRF design
• CRF development
• CRF quality assurance
• CRF approval process
• CRF version control process
• Applicable training of site personnel on CRF use
- Good Clinical Data Management Practices - SCDM