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Compliance In Focus
Posted by John Lehmann on Thu, May 2, 2013

How to Select OUTSTANDING Sites!

Selecting outstanding sites is the key in running a well-controlled clinical trial.  Failure to identifydescribe the image outstanding sites could result in added costs and could lead to delays in bringing much needed products to the bedside.  Investing upfront time in the selection process could yield a positive return.  Today’s clinical research landscape typically allows for minimal resources under tight timelines, requiring sponsors to quickly, yet effectively, decide which sites are the right fit for the job. Selecting sites is the responsibility of the sponsor as outlined in ICH-GCP 5.6.1, 21 CFR 812.43, 21 CFR 312.50, and ISO 14155:2011(E). There is not a great deal of detail in these regulations to provide further guidance to sponsors. It is truly the sponsor’s responsibility to take the time at the start of the study to carefully examine potential sites and ask important questions during the review process.

  • What does the sponsor need to look at to determine if a site is outstanding?
  • What are some important questions to ask in relation to the sponsor’s study?
  • Is there an easy way to weed out sites that are not efficient or effective?

IMARC’s most recent whitepaper dives into these questions and takes an in-depth look at what sets sites apart and allows them to shine as OUTSTANDING! Use and learn what being an OUTSTANDING site means and how to use OUTSTANDING to select high performing, compliant sites.

O-Organized

U-Unified study team

T- Trained study staff/Therapeutic Expertise

S-Sufficient amount of staff

T-Time and costs

A-Adequate facticity

N-New to research or well experienced

D- Data! Timely, accurate, and complete

I-IRB status

N-Number of potential research patients

G- Good reputation of the PI and Co-Is

Please take time to download IMARC’s newest whitepaper-Outstanding Sites: “Selecting OUTSTANDING Sites to learn more about the importance of site selection.”

Outstanding Sites

Topics: IMARC Research, Outstanding Sites, Site Selection

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