Study Startup: Top 5 Stumbling Blocks & What To Watch For


Congratulations! You received the greenlight on your latest study and the team is ready to start screening subjects. As you sit back and wait for the inevitable screen failures and other challenges ahead, you are wondering how best to keep the sponsor happy.  What are the top 2 traits sponsors look for in sites during study startup? Well, that’s a no-brainer: accuracy and expediency. But how do you consistently achieve said objectives? Consider the 5 tips that will help you achieve your goals more efficiently.

  1. Details, Details

Something as small as your investigator’s name on their curriculum vitae can trip up a study start. You may run into instances where their legal, working or married name is different from the name on their regulatory license. Perhaps there was a typo, transcription error, or a middle initial left off a document. These little details, also known as human error, can happen all the time. It is probably one of the easiest to correct but most frustrating study stumbling block.

A classic small issue we’ve seen numerous times is something as simple as not having the proper study supplies on hand that are mandated by your sponsor or CRO. Perhaps you are conducting a trial that requires specialized equipment, often specifically provided by a supplier contracted with the sponsor. That supplier could be based out of the country and consequently its materials will have to go through customs. We all know what a beacon of efficiency customs is.

  1. Incomplete Documents

The sponsor themselves may not have pre-populated the FDF (Financial Disclosure Form) with sponsor specific information. FDFs that needed the headers filled in may not already have the sponsor’s name, protocol number, or protocol title.  You may have even had those sections incomplete and blocked for editing.  It may not seem like a burden to just fill that information in, but when you are processing multiple regulatory documents, and saving them in multiple repositories, more mistakes will happen. All of this could have been avoided if they were sent out with the sponsor/study information.

Perhaps the 1572 was not completed with IRB information and/or central laboratory information. Only the sponsor/CRO will know what IRB is being used and what central labs are involved. As you know well, there are usually several of those.

Lastly, you finally have all the documents you need when a new wrench is thrown in. You may receive additional documents for completion just hours before the SIV or during the SIV.  Usually greenlight is contingent on the completion/submission of these forms and availability on site of all supplies, for example: Source Doc Agreements, Blinding Plans, Recruitment Plans and really, anything else a creative regulatory team can come up with.



  1. IRB Protocol

Has this happened to you?  The sponsor provides sites with a protocol that is still under IRB review for approval or sends a protocol knowing an amendment is to follow.  There are a few reasons for this. There may be a delay in site IRB application because IRBs will not review a site application if the sponsor’s study/protocol is not already IRB approved.   Or sponsors will send a protocol knowing an amendment is under IRB review for approval.  While there are good reasons for these incidents, it causes double work for regulatory compliance and possibly for the lead SC or Marketing.  If there are changes to the source, inclusions or exclusions, he or she will have to rework those documents and in some cases recruitment materials.

The Model ICF may not be ready.  This could be out of the sponsor’s control – it needs to be reviewed and approved by the IRB before they will allow sites to have access to it. If the ICF isn’t ready, simply communicating that to sites is helpful. However, for sites that have standard edits to each ICF specific to their site, this delays them from submitting to the IRB. It is good practice to review the model ICF to ensure the information is accurate and aligns with the site, and free of typos.  You could find mistakes in the ICF or information that may not reflect accurately of the site after it has been IRB approved.  This causes the site to submit for a change with the IRB, creating unnecessary paperwork/work. Are you sensing a theme here?

  1. Communication Issues

Sites will experience a lack of communication in a variety of ways: with the point of contact for startup, CRA, recruitment, timelines, the site number (which will often be captured on startup forms), enrollment goals, and so on. Staying on top of your latest point of contact with proactive and consistent communication is the best way to head this off.

Sponsors may not identify or communicate required study training’s in a timely manner.  Often lead Study Coordinators are unaware of what training will be required per each role in the study. In many cases, SCs must hunt down training in order to receive greenlight. Therefore, the quicker this is identified and communicated, the quicker staff can work on completing and submitting their training.

  1. Unanticipated Delays

Delays are maddening, often unexpected and usually unwelcome. For example, there may be a snag in budget negotiations. Sites must inform the IRB of subject stipends for that to be incorporated in the ICF.  The IRB may review stipends to ensure subjects are being paid an appropriate amount.  IRBs will not review the initial application for approval unless this is identified.  Did we say how maddening this is?

When it comes to clinical research, the path to a successful study start may look more like a zig zag than a straight line when you’ve got regulatory compliance to worry about. Knowing what to look out for should help your next start, making it a bit less rocky. That, and a good e-Reg software, of course. Check out eRegBinder and learn about how it can solve at least a few of these startup issues.