‘Escalation’ is usually treated as some very strong word meaning someone is in trouble causing some goose bumps when one sees this word in email subject line. For clinical research operations, escalation is more like a routine (depending on the severity, of course). During contract negotiations, the negotiator deals with the escalations every other day (exaggerating – let’s say, often) being not an object for escalation, but the one who initiates escalation.

Reasons behind can be innumerable – non-responsiveness, delays, unreasonable behaviour, etc. Let’s focus here on escalations initiated by the negotiator due to site’s issues. What, where and when shall be escalated, and the main question, to whom:

• To the Principal Investigator (PI).

It might work out if the negotiator deals with the PI who is really involved and motivated for the soonest site initiation possible. Should a negotiator face delays in site’s response or any site-initiated issues, there should not be an issue at least to cc the PI in a follow-up email, or give the PI a call, where appropriate.

A real life example: study coordinator (SC) – who was also assigned to be responsible for contract negotiation – was so busy with the clinical aspects of the study that simply lost track on where the contract really is, yet it was a kind of embarrassing for the SC to admit that, and she kept telling the negotiator that the contract was still under site’s review, and the negotiator should have been more patient. Patience is a good thing, but when the review takes much longer than usual, the negotiator asks the PI to pay attention to the situation – as a result, just in few days the negotiator receives the revised contract version from the site.

What is critical here: the professional negotiator’s escalation is not a finger pointing activity. A contract negotiator should escalate to settle the issue, while taking responsibility for that. Okay, in the example above the SC might not be correct, but maybe the SC just needed some help – we never know the exact situation at the site, thus helping attitude is the one that shall be applied.

• To the Internal Study Team (Contracts/Start-Up/Project Manager).

This type of escalation is often used during the regular project updates meetings (if there are any) or it is specifically marked during the tracker updates (please check also how to stop being afraid of trackers). It depends on the communication – plan or ‘custom’ – you have with the Team, but anyway the issue should be disclosed to them even if the negotiator can solve it by him/herself.

• To the Line Manager (LM).

Surely, every negotiator, employee or freelancer, has regular meetings with their LM. The content of such meetings can vary and can be focused, for example, on HR-related topics only, but if there is some issue the negotiator is experiencing with the site, it should be communicated to the LM (at least as FYI). It might be that the issue is something the LM faced earlier and the LM has a solution to suggest.

• To the Sponsor.

Sponsor is the final authority. While escalating to the Sponsor, the negotiator must follow the agreed communication plan (to check if the negotiator can escalate directly, or some internal steps shall be made before, or only some of the above managers can escalate etc.) Usually, if the negotiator does have direct communication with the Sponsor, this communication happens when all the above listed options are tried.

We see, escalation shall be the result of the negotiator’s thoughtful and timely decision. To escalate shall mean to help solving or preventing the issue. In no way it should be a finger pointing or anything offensive creating even more problems.