Introduction Direct observation of clinical skills is a key assessment strategy in competency-based medical education. The guidelines presented in this paper synthesize the literature on direct observation of clinical skills. The goal is to provide a practical list of Do’s, Don’ts and Don’t Knows about direct observation for supervisors who teach learners in the clinical setting and for educational leaders who are responsible for clinical training programs.

Methods We built consensus through an iterative approach in which each author, based on their medical education and research knowledge and expertise, independently developed a list of Do’s, Don’ts, and Don’t Knows about direct observation of clinical skills. Lists were compiled, discussed and revised. We then sought and compiled evidence to support each guideline and determine the strength of each guideline.

Results A final set of 33 Do’s, Don’ts and Don’t Knows is presented along with a summary of evidence for each guideline. Guidelines focus on two groups: individual supervisors and the educational leaders responsible for clinical training programs. Guidelines address recommendations for how to focus direct observation, select an assessment tool, promote high quality assessments, conduct rater training, and create a learning culture conducive to direct observation.

Conclusions High frequency, high quality direct observation of clinical skills can be challenging. These guidelines offer important evidence-based Do’s and Don’ts that can help improve the frequency and quality of direct observation.