Assess your institution’s infrastructure and resources

Obtain feedback on the trial from key staff

  • Look at the protocol requirements through the eyes of staff who may be involved—from nurses, to research coordinators, to the pharmacy, to the lab.
  • Share the protocol with investigators, the research team, and people from the other departments that will be involved.
  • Ask questions to understand operational issues such as scheduling and resources.

Assess the financial burden of the trial on your institution

  • Spell out the costs (and benefits) of the proposed trial to your institution before opening the trial.

Assess the capacity of your institution to conduct the trial

  • List what the study will demand of your facility—for example, workspace, lab needs, pharmacy needs.
  • Are new skills required?
  • Does the protocol require new or complex internal processes or special equipment?
  • Where do you see needs that may exceed capacity? What, if anything, can be done to improve or expand capacity in those cases?

Determine if you have adequate staffing levels

  • Be thoughtful about the staffing requirements for the new trial and how trial activities fit with current work.

Literature and Tools (61)

Image Representing Resource Type (Journal Article)
Effort Required in Eligibility Screening for Clinical Trials.
Posted: Feb 13, 2013.
Penberthy LT,Dahman BA,Petkov VI,DeShazo JP. Journal of Oncology Practice. 2012 Nov. 8. 6. 365-70.
KEYWORDS: Institutional Issues, Eligibility, Cancer
Image Representing Resource Type (Journal Article)
The process of developing audiovisual patient information: challenges and opportunities.
Posted: Feb 13, 2013.
Hutchison C,McCreaddie M. J Clin Nurs. 2007 Nov. 16. 11. 2047-55.
KEYWORDS: Knowledge/Attitudes/Beliefs, Staff Experience Level, International, Cancer, Treatment
Image Representing Resource Type (Journal Article)
Strategies to engage clinical staff in subject recruitment.
Posted: Dec 18, 2012.
Segre LS,Buckwalter KC,Friedemann ML. J Res Nurs. 2011 Jul 01. 16. 4. 321-32.
KEYWORDS: Level of Clinical Trials Knowledge or Awareness, Incentives, Attitudes, Institutional Issues
Image Representing Resource Type (Journal Article)
Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy
Posted: Oct 01, 2012.
Longbottom ME,Roberts JN,Tom M,Hughes SE,Howard VJ,Sheffet AJ,Meschia JF,Brott TG,for the CREST Investigators. International Journal of Stroke. 2012 Aug. 7. 6. 447-53.
KEYWORDS: Institutional Issues, Inadequate Staffing, Eligibility, Web, Non-Cancer
Image Representing Resource Type (Journal Article)
The impact of concomitant medication use on patient eligibility for phase I cancer clinical trials.
Posted: Sep 28, 2012.
Borad MJ, Curtis KK, Babiker HM, Benjamin M, Tibes R, Ramanathan RK, Wright K, Dueck AC, Jameson G, Von Hoff DD. J Cancer. 3. 345-53. 2012 Aug 17. [Epub ahead of print]
KEYWORDS: Staff Experience Level, Institutional Issues, Eligibility, Study Burden, Cancer, Phase 0,1,2

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