Table 2

Frequency of longest continuous delay reasons for SANAD-II sites that took over a specified time to complete milestones

MREC to SSI Submission >3 months
 Excess Treatment Cost Negotiation16
 Finalising logistics ie, SSI completion, identifying staff*11
 Collecting CVs10
 Participation Discussions: ie change of PI, ongoing feasibility10
 Not a priority site for SANADII staff‡7
 Awaiting R&D permission to submit SSI§5
 Waiting for PI to sign SSI3
 Resolving R&D query/s2
 Pharmacy approval1
 Local ethics1
 Site research team holding off set up¶1
 No news from network1
 No response to email**1
69
SSI Validation to R&D Approval >30 days
 Waiting for contract to be signed by site3
 Unknown delay3
 Waiting for training on trial procedures1
 Contract being signed by sponsor1
 Contract review by site1
 Excess Treatment Cost Negotiation1
 Governance query1
 Waiting for staff to come into post1
12
R&D Approval to Opening > 30 days
 CTU waiting for completed delegation log5
 Waiting for training on trial procedures4
 Waiting for site to sign contract2
 Waiting for R&D approval letter2
 CTU waiting for Acknowledgement receipt of Essential Documents1
 Waiting for sponsor to sign contract1
 Waiting for staff to come into post1
 Waiting for staff to do GCP training1
 No response to email§1
18
  • Where some delay reasons have been grouped the text in italics indicates the most frequent codes used in the grouping. The wording of some delay code names for smaller frequencies have been adapted to give better understanding of the actual delays based on notes made at data collection.

  • *Included SSI completion (n=9), identifying staff (n=1) and agreeing recruitment target (n=1).

  • †Included change of PI (n=8), feasibility discussions (n=1), decided not to participate but are now participating again (n=1).

  • ‡This reason increased from interim analysis in October due to the reduction in staff (trial coordinator assistants) towards the end of 2013. As a result trial staff prioritised proactive sites and weren't able to follow-up less proactive or new sites.

  • §R&D holding off submission possibly due to internal issues (n=1), R&D were reviewing the SSI before formal submission (n=3) and research network informed us they were waiting for R&D permission to submit the SSI (n=1).

  • ¶Research staff at site did not have capacity and requested that contact be re-established in 3 months.

  • **No response from clinical staff.

  • CVs, Curriculum Vitaes; SSI, Site Specific Information; R&D, Research and Development.