So, you have just been assigned to a new project and you are all excited to start and hit the targets as the clinical trial agreement functional lead. You have attended the kick off meeting, gotten to know the project team, the study protocol is final, the country specific study budget and clinical trial agreement templates have been prepared and you are ready to launch negotiations and rock it this time!
With great enthusiasm, you distributed the country level clinical trial agreement template and study budget. The negotiations with the sites can start now. However, within a few days, the news came back; the sites will not accept the prepared country specific template. It seems that they have their own site or regional template or country level industry template.
What do you do?
Naturally, you asked more questions, hoping to elicit information about the template. You hope to gain more insight as to whether the site/regional/country level industry template is negotiable or mandatory. The preference is to of course use the template you have prepared for the project.
To your disappointment, the answers you get are non-committal. Perhaps, even confusing. How frustrating!
What do you do next?
Do you escalate to your internal manager or even your legal department and ask for approval to go ahead with the site/regional/industry template? Perhaps you are with a CRO, so do you approach your sponsor at this point?
Time ticks away, and everyone seems to be making progress except you. Not a comforting feeling!
Does this sound familiar to you?
If you find yourself in the situation described above, consider the following steps before escalating up.
1. Go back to the basics. Start off by having a good look at the site/regional/industry template and assess first and foremost, the contractual framework of the template.
Is the contractual framework in the site/regional/industry template consistent with the contractual framework agreed for the study? For example, if you are with a CRO and the agreement with the sponsor is for the CRO to enter into the clinical trial agreement as a party, does the site/regional/industry template reflect this agreed set up? If the site/regional/industry template is written with the sponsor as the party, then in the example mentioned beforehand, you will need to be aware that the contractual framework is essentially different than what has been agreed with the sponsor. This is an important point to pick up as the roles and risk profile of a sponsor and a CRO are different. Ideally, you would want to have these reflected in the clinical trial agreement. In most instances, replacing references of sponsor with CRO will not be sufficient if you are looking at apportioning the roles and risks appropriately. In addition, a clinical trial agreement that makes clear whether the sponsor or CRO is the contracting party and services recipient will also help ensure correct invoicing and proper application of tax regulations.
2. If the site/regional/industry template is not consistent with the agreed contractual set up for the project, make a general assessment as to how much revisions are needed to adjust the template into the agreed framework for the project. In parallel, connect with your local team and try to understand the implications in terms of costs and time should you decide to pursue with negotiations to amend the site/regional/industry template.
3. Review the site/regional/industry template against sponsor’s or CRO’s must haves as applicable. Does the template cover the must-haves in any way? Does it have any language that is contrary to the must haves?
4. Make a quick overall assessment of the template. Does it reflect what your organization would consider a standard clinical trial agreement template? Does it contain the main clauses that you usually see in a clinical trial agreement? Will you end up re-writing the site/regional/industry template if you start modifying it to fit your ideals? Or perhaps, only minor revisions are needed? If you need to modify the contractual framework, what is the feedback from your local team (see item 2) and what is the extent of the revisions.
5. Ask yourself what will be the best solution considering the timelines, contractual framework agreed at the project level, must-haves, willingness of the site(s) to negotiate, local requirements and how important the site(s) is/are to the study. Can you make any strategic concessions and can you meet the site in the middle if there are indications of willingness to negotiate? If the template is not ideal and it is clear that the site is not willing to co-operate, do you have a back up plan?
6. Reduce your assessments and solutions in short into writing and support it with “whys”. Don’t forget to add any background information briefly.
7. Now, you are ready to escalate up. Present the situation, your assessments and suggested solutions. Include a call to action– ask for approval, further instruction or advice on the next step, and be specific about when you need the approval, instruction or advice.
Follow up diligently until a decision has been made on how to proceed further. Needless to say, you will need to ensure that the escalation path, negotiation plan or applicable processes are followed but the above considerations should guide you on what to do when escalating up.
If you put the above in practice, I am confident that you will sow the benefits of your hard work. You will get the issue resolution process going in positive light as you exhibit ownership and proactivity.
So, the next time you become inundated with the unknown, go back to the basics, do what you can within your control, trust your own assessments, share it and connect with the team members in the next escalation level as a partner in the issue resolution process.
Stay engaged in the process.
