Each site should develop a site-specific procedure that identifies the steps that should be taken if an event or rumor threatens to undermine community trust or trial credibility. The sites should work in partnership with networks and collaborating institutions (when appropriate) before the study begins (or as soon as feasible). The procedure should clearly identify the roles and responsibilities of key staff members and the steps that should be taken in the event of a communications crisis.

1. Staff learns of a problem or a potential problem and reports it to [name of designated management contact].
2. Management shares information with crisis communications team by telephone or e-mail.
3. Site coordinator or principal investigator (PI) investigates and shares findings with crisis communications team and with upper management as appropriate.
4. Crisis communications team convenes an urgent conference call, does a rapid assessment of the situation, and prepares an appropriate plan of action. (This may include deciding to take no action.)
5. The team prepares an internal Q&A or holding statement, if necessary, and shares it with relevant staff members. For example, “A __ at __ involving __ occurred today at __. The incident is under investigation, and more information is forthcoming.”
6. If the situation has not resolved, the crisis communications team outlines and shares a communications plan that is devoted to the situation. This plan will designate a spokesperson and include recommendations on whether and when to issue a holding statement.
7. The team’s plan and prepared documents are shared with primary stakeholders (to be identified, case by case). These may include ministry of health officials, donors, or investigators who lead studies that are testing the same product.
8. The crisis communications team implements the situation-specific crisis communications plan—including a more substantive statement, Q&A for reactive use, media scan, and a log of media inquiries and coverage.
9. The crisis communications team and senior management agree on which external experts to brief and refer journalists to and what, if anything, to tell other key people in the wider community (including other researchers or key people in the field) who are likely to be contacted for comment. The communications team notifies experts and other key persons by telephone. An e-mail advisory might be necessary if the situation is complex.
10. The crisis communications team ensures that spokespersons rehearse tough questions.
11. As the situation unfolds, the crisis communications team “meets” regularly to discuss progress, media reports, inquires received from news media or influential trial stakeholders, how inquiries are being handled, and additional steps needed to keep others, including the public, informed.
12. The crisis communications team holds a debriefing meeting once the situation is resolved, then documents what happened and what was learned from it (for internal use and to share lessons learned with the field, as appropriate).

Source: PATH, Rotavirus Vaccine Program. Clinical trial communication planning to manage risks. Washington (DC): PATH; 2007.