Best Practice Tips for Clinical Research Coordinators Getting from Why Can’t I to How Can I? Cynthia Knauer RN,MS, AOCN Research Nurse Coordinator Department of Urology

Objectives At the end of the session, the clinical research coordinator will be able to: o Identify tools to assist with subject recruitment and retention. o Identify tools to assist with team participation in research projects. o List ways to prepare for study visits.

Subject Recruitment and Retention Cheat sheet listing Title of protocol/ Approval dates/ inclusion/exclusion criteria and Coordinator contact info on card for phone consults PDF version of approved consent to send for review (potential subject and family, S.O) [Secure] Outline of protocol visits with specific required testing designated as Standard of Care or for Research to explain this concept to subjects to understand what their insurance will be billed for versus what it will not

Subject Recruitment and Retention Provide calendar of study visits. Schedule next visit at completion of first visit to allow for confirmation of imaging or treatment space. Allows for review of subjects calendar to accommodate personal plans and still be within protocol window. Maximize number of protocol procedures per visit to decrease travel. Provide contact number for questions regarding protocol visits, change of schedule, billing for research procedures.

Cheat sheet listing Title of protocol/ Approval dates/ inclusion/exclusion criteria and Coordinator contact info on card for participating referral practices (One Note) PDF version of approved consent available if requested or printed copies of consent in file drawer of consult office. (G drive) Outline of protocol visits with specific required testing designated as Standard of Care or for Research (need two types of visits scheduled) SMART PHRASES ( Informed Consent, Study Day 1 etc. Flow sheets Team Participation

SMART PHRASES ***GCO # ( Dissecting Tumor Heterogeneity) ***for study which has been reviewed only***Purpose, procedures, benefits and risks for TUMOR HETEROGENEITY study reviewed by (***name of person obtaining consent***). Opportunity to ask questions provided. Confirmed through asking of questions that the subject/representative understands the information provided, does not feel pressured by time or other factors to make a decision, understands that this is a voluntary choice to make and that they are capable of making and communicating an informed choice. Consent executed through signature and date. Copy given to subject and scanned into EMR. Original placed in regulatory binder.***

SMART PHRASE in Practice GCO # ( GU DATABASE) Purpose, procedures, benefits and risks for GU DATABASE study reviewed by (Taleen Bolbolian). Opportunity to ask questions provided. Confirmed through asking of questions that the subject/representative understands the information provided, does not feel pressured by time or other factors to make a decision, understands that this is a voluntary choice to make and that they are capable of making and communicating an informed choice. Consent executed through signature and date. Copy given to subject and scanned into EMR. Original placed in regulatory binder. GCO # (Mount Sinai Cancer Biorepository) Purpose, procedures, benefits and risks for Mount Sinai Cancer Biorepository study reviewed by Taleen Bolbolian. Opportunity to ask questions provided. Confirmed through asking of questions that the subject/representative understands the information provided, does not feel pressured by time or other factors to make a decision, understands that this is a voluntary choice to make and that they are capable of making and communicating and informed choice. Consent executed through signature and date. Copy given to subject and scanned into EMR.

Preparing for Visits Visit Day_____ A week before confirm visit with subject, imaging, treatment area Prep study kits( confirm you have correct kit, shipping materials for visit. Label tubes with study id and other info minus date time of collection until collected Collate CRF’s or source documents to facilitate source documentation Streamline visit to minimize venipuncture ( tough stick, angiocath prior to imaging or bring study tubes to imaging to be drawn at line placement for contrast) Schedule next visit