1. Welcome to The C.R.I.E.R. Project (Clinical Research Investigators’ Electronic Record) A cooperative project to assist in development and execution of small scale clinical research projects. C.R.I.E.R. and C.R.I.E.R. -Lite are proprietary MS- Access® computer program-products developed by researchers from the Baylor College of Medicine section of Medical Gastroenterology and Kennedy Data Solutions. For licensure information, please contact: skennedy10@@sbcglobal.net (remove one @) Disclaimer: This software is intended to support organizational needs for INVESTIGATOR- INITIATED TRIALS (IITs) and internal pilot studies. This software is not intended to replace primary source documentation and may or may not meet requirements needed to support data submissions to the FDA, as conditions will vary depending upon intent and application. Users should consult with regulatory affairs experts.

2. The C.R.I.E.R. Project Clinical Research Investigators’ Electronic Record (CRIER™) and CRIER-Lite™ are customized database programs and compendium of data entry forms, developed using Microsoft Access® application (MS-Office 2000 or later edition). The base program permits easy capture of discrete data and narrative clinical information (variables and outcomes) concerning human research study subjects participating in clinical trials. The base program can be easily re- configured to capture study-specific outcomes and adapt to most clinical trial needs. Both products can be adapted to work with a complimentary program for logging clinical research specimens called URSALA™ (Uniform Research Specimen Accounting Log for ACCESS®. Background programming in Visual Basic™ offers protection against serious data entry omissions, reference range violations, inclusion and exclusion criteria violations, and data entry errors.

3. The C.R.I.E.R. Project The CRIER® products permit the real-time creation of source documentation or organization of transcribed clinical research data as e-Case-Report- Forms (eCRF). The CRIER® products facilitate the monitoring of outcomes, including medical history, physical features, and laboratory tests; study- specific outcomes, adverse experience documentation with simultaneous data management for long-term electronic storage, for tabulated retrieval and for critical variable analysis. It is designed with the investigator and the data safety monitor in mind. Field and clinical personnel can simply upload CRIER™ or CRIER-Lite™ to the primary investigator or data safety monitor on a scheduled basis (e.g. daily or quarterly) for review.

4. The C.R.I.E.R. Project CRIER-Lite is streamlined and incorporates summary information, on the assumption that there are paper-documentation (source documents) that are unlikely to play into outcome analyses (safety or scientific). The product is unique because of its safety-monitoring features (e.g., pop-up alerts to critical values) and its versatility (adaptability). The product eliminates the need to re- enter data from paper case report forms (CRFs) and should minimize transcription errors. Completed forms are printable for immediate authentication and certification as source documents for the bedside chart. Other features include ongoing medication monitoring, safety laboratory alerts and adverse event recording. A reactogenicity module (add-in) is available for monitoring recurring study-specific outcomes. Enjoy your tour!

5. CRIER and CRIER-Lite both allow entry by password and include different levels of data entry/change capabilities.

6. Drop-down lists of entry data ordered by critieria.

7. The values and color-coding to the left are automatically set by the input in other forms – Red, Green or Orange.

8. Entry by Site Investigator- level only Entry by Auditor or PI-level only

9. Many forms include requirement to enter certain fields if any data is entered on form, i.e., Person Performing H & P.

10. Many forms are repeatable for the same and for multiple visits.

11. Once all of the Inclusion / Exclusion criteria are marked, the eligibility is automatically marked on this form, Subject Information form and the enrollment form. If the subject is not eligible, some forms no longer allow entry.

13. Examples of flags that require specific input prior to continuing with that form’s input.

14. Subject was automatically randomized to a group according to a randomization scheme set in the program.

15. This is an alternate medication record format for data input allowing for ease of entry of standardize d values by clicking buttons or by typing in values.

16. Printable calendars to give subjects with specific dates or date ranges for future visits.

25. Concierge Services Optional customized forms with calculated values using complex Visual Basic codings

27. Kennedy Data Solutions’ Concierge Service can produce more elaborate forms such as the Study Outcomes in the full CRIER database.

30. Kennedy Data Solutions can design a database to fit your needs. Please view all 4 presentations: CRIER, CRIER-Lite, URSALA and STAR, to view the various formats available. Contact Susan Kennedy at 832-687-6301.