Please review the Willingness to Participate section at the bottom of the form prior to submission.

DURATION OF STUDY

YEAR 1: October 2015 through April 2016 (Pre-Study, Baseline)

YEAR 2: May 2016 through April 30, 2017 (Implementation, Intervention)

APPLICATION INFORMATION

BRIEF STATEMENT OF INTEREST

BRIEF DESCRIPTION OF CTSA

VOLUME OF PROTOCOLS (Please use 0 if not applicable, and include any additional comments)

STANDARD OPERATING PROCEDURES OR DESCRIPTION OF CURRENT SRC PROCESS (if applicable)

LETTER(S) OF SUPPORT

Letter(s) of support from the IRB Chair and/or Institutional Official should be sent to Aaron Kirby (akirby@tuftsmedicalcenter.org) by Friday, October 9, 2015. If you anticipate a delay in obtaining a letter of support, please notify Aaron Kirby prior to Friday, October 9, 2015.

WILLINGNESS TO PARTICIPATE INCLUDES:

• After the initial baseline pre-intervention phase, following the SRC processes or provide explanations for any variations in process due to institutional needs. Please see Consensus Report on the Scientific Review Processes, Appendix A.
• Collecting pilot study metrics. Participation in the pilot study will entail collecting the evaluation metrics prospectively during baseline and intervention phases (see Appendix B, Study Approach). In addition, within the first two weeks of the pre-study phase, participating CTSAs will submit retrospective preliminary data including, but not necessarily limited to, the following data points:
  
  • Number of clinical trial protocols reviewed by IRB in 2014 for the last 12 months
  • Number of clinical trial protocols reviewed by SRC in 2014 or the last 12 months (if applicable)
  • Number of days for IRB and SRC review. Use the 2014 calendar year (or the last 12 months) to calculate the mean, standard deviation, median, minimum, maximum, 25th and 75th percentiles, for:
    • Number of days from clinical study submission for the ethical review (including scientific review, if applicable) until approval. If scientific review is separate from IRB review, then a categorization of the number of days into two components: IRB review and scientific review. Please indicate whether scientific review is conducted by SRC, or another process.
    • Number of days that clinical protocols are with PI for revisions during the IRB process
    • Number of days that clinical study protocols are with PI for revisions during the scientific review process, if applicable.
• Collecting and submitting data to the pilot study's electronic data capture system in an ongoing manner for the duration of the study 
• Being available for one site visit from Tufts CTSI Project Manager
• Participating in a pre-study protocol training webinar and monthly phone calls with Tufts CTSI Project Manager
• Participating in one semi-structured key informant telephone interviews by the Site Principal Investigator during the pre-study or baseline phases of the project. (Additional key informant interviews may be requested during the implementation period.)

PLEASE DIRECT ALL QUESTIONS TO:

Aaron Kirby, MSc

Manager, Project Administration

Tufts Clinical and Translational Science Institute (CTSI)

Email: akirby@tuftsmedicalcenter.org