*Study Title (Protocol Number)*

**Participant Recruitment, Retention and Adherence Plan**

**\[Required components of the plan are in bold non-italicized font.**
*Suggested approaches and strategies and study-dependent components od
the plan are in italicized font.***\]**

I.  **Pre-initiation phase**

    A.  **Determine protocol staff assignments and document
        assignments**

        1.  *Assign dedicated recruitment coordinator*

        2.  *Assign alternate recruiters*

        3.  *Determine site PI role*

            a.  *Determine involvement (e.g., meet with every
                participant? consent every participant? see participant
                at every visit? etc.)*

            b.  *Assure PI availability to coordinator*

            c.  *Give appropriate decision-making authority to
                coordinator*

            d.  *Monitor recruitment*

            e.  *Meet w/ protocol staff regularly*

        4.  *Plan consistent site staff and trial contacts for patients
            (e.g., coordinator, PI, receptionist)*

    B.  **Evaluate protocol design with respect to "recruitability"**

        1.  *Evaluate feasibility of sample size*

            a.  *Consider availability of target population considering
                demographics*

            b.  *Consider availability of target population considering
                eligibility criteria*

        2.  *Consider protocol design effects on recruitment*

            a.  *Possible effects of placebo*

            b.  *Possible effects of participant access to study drug if
                it is FDA-approved*

            c.  *Possible effects of potential toxicity*

            d.  *Possible effects of complicated entry criteria and
                burdensome protocol procedures*

        3.  *Calculate availability of eligible participants based on*

            a.  *Consult with potential participants - consider
                feasibility study/survey*

            b.  *Review patient lists within each practice*

            c.  *Review the literature*

            d.  *Calculate*

                1.  *Number of [eligible]{.underline} participants at
                    each site*

                2.  *Estimate number of eligible enrolled participants/
                    total eligible participants*

            e.  *Estimate accrual time (participants/month)*

        4.  *Consider protocol modifications (if recruitment goal is
            unrealistic)*

            1.  *Consider broadening eligibility criteria*

            2.  *Consider simplifying protocol*

            3.  *Consider decreasing sample size*

            4.  *Consider extending recruitment period*

> []{.mark}

C.  **Identify referral sources**

    1.  *Contact referral bases*

        a.  *Advocates*

        b.  *Retirement communities*

        c.  *Senior centers*

        d.  *YMCAs, JCCs, etc*

        e.  *Health clubs*

        f.  *MD referrals*

        g.  *Churches*

        h.  *Community centers*

        i.  *Corporate strategies (i.e., enlist endorsement and
            cooperation from local industry to promote enrollment)*

        j.  *Alliances with disease specific organizations*

            1.  *Patient advocacy groups*

            2.  *Support groups*

            3.  *Charitable organizations*

    2.  *Cultivate working relationship with non-oncology specialists
        (e.g., GI, surgery, pulmonologists, ENT, gyn)*

    3.  *Survey potential referral doctors, get letter of commitment if
        possible*

    4.  *Re-evaluate sample size*

D.  **Determine and document metrics for evaluation of recruitment and
    retention performance**

    1.  **Plan for quick recognition of lagging enrollment**

        a.  **Create and document recruitment timeline with milestones
            and evaluation points**

        b.  *Plan to monitor and document task completion for
            timeliness*

            1.  *Regulatory requirements*

            2.  *Weekly meetings*

            3.  *Meeting minutes*

    2.  **Plan to evaluate and document strategies: outcomes**

        a.  **Plan to track number of participants enrolled in a defined
            time period as a result of each strategy**

        b.  **Create screening log forms with attribution to specific
            strategy and reasons for ineligibility, or non-enrollment**

        c.  **Plan to calculate cost of enrollment per participant**

        d.  **Plan to maintain and monitor screening/enrollment logs**

        e.  *Plan survey of participants' opinions re: strengths and
            weaknesses of strategies*

    3.  **Plan to track participant withdrawals and reasons for
        withdrawal**

E.  **Train staff**

    1.  *Educate all participating staff re: protocol (after protocol is
        approved)*

    2.  *Develop and distribute protocol pocket cards*

    3.  *Provide Frequently Asked Questions document*

    4.  *Train support staff*

        a.  *Smooth clinic flow and hospitality*

        b.  *Procedural requirements (e.g., fasting)*

        c.  *Prepare procedures for when protocol is violated*

    5.  *Prepare script of protocol explanation*

F.  **Promote comfortable and pleasant clinic environment/experience**

    1.  *Supply driving directions to schedulers*

    2.  *Coordinate well-organized clinic flow*

    3.  *Assure user-friendly test scheduling, drug dispensing, etc*

    4.  *Negotiate (if possible, insist upon) flexible appointment times
        (i.e., more than one day per week)*

    5.  *Plan to allow ample time for participants with the clinical
        trial staff*

    6.  *Schedule periodic meetings between the clinic coordinator and
        the protocol staff meetings*

G.  **Ensure adequate budget**

    1.  *Adequately compensate staff*

    2.  *Consider recruiter's transportation to community, meetings*

    3.  *Consider participant compensation*

    4.  *Cover recruitment, retention and adherence tools (e.g.,
        newsletter, mailings, protocol pocket cards, participant visit
        calendars, etc.)*

H.  **Determine recruitment and retention strategies based on evaluation
    of protocol, target population, clinic, referral sources**

    1.  *Contact and inform referral sources*

    2.  *Advertisements*

        a.  *Newspaper*

        b.  *TV*

        c.  *Radio*

        d.  *Internet*

        e.  *Direct mailings*

    3.  *Public relations*

        a.  *Investigator interviews*

        b.  *Patient education*

            1.  *Investigator or coordinator educational sessions to
                relevant community*

            2.  *FAQ documents*

    4.  *Recruiters/study staff support*

        a.  *Newsletter for study sites/ consortium*

        b.  *Teleconferences for study sites/consortium*

        c.  *Recognition of high recruiters (within consortium or study
            site)*

        d.  *Frequent contact with participating site coordinators*

    5.  **Minority recruitment strategies**

        a.  *Perform cultural assessment of local community*

        b.  *Consider centralized minority coordinator*

        c.  *Consider matched ethnicity recruitment coordinator*

        d.  *Have translator available*

        e.  *Minority community liaison*

        f.  *Meet with minority community leaders*

        g.  *Go to community*

            1.  *Meetings*

            2.  *Churches*

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II. **Active recruitment phase**

    A.  **Implement strategies as determined during pre-initiation phase
        of plan**

    B.  **Assess eligibility of individual potential participants**

        1.  *Begin supportive relationship with patient*

        2.  *Consider poor adherence and retention potential*

            a.  *Exclude participants unlikely to comply and stay on
                study -- unless you can provide compensatory support and
                follow-up*

                1.  *Known history of non-compliance/adherence*

                2.  *Socially unstable*

                3.  *Expressed difficulty with and numerous objections
                    to protocol requirements*

                4.  *Cavalier attitude toward protocol*

                5.  *Verbalized minimization of cancer risk*

                6.  *Verbalized "active drug only"*

    C.  *Explore participant's objections to enrollment*

        1.  *Clarify any misconceptions*

        2.  *Offer to resolve manageable logistical problems*

        3.  *Consider multiple objections as red flag indicating
            possible retention/compliance problems*

    D.  *Involve participant's social network in decision-making*

    E.  **Continuously evaluate strategies as planned during
        pre-initiation phase of plan**

        1.  *Monitor and document task completion for timeliness*

            a.  *Regulatory requirements*

            b.  *Weekly meetings*

            c.  *Meeting minutes*

        2.  *Evaluate and document strategies: outcomes*

            a.  *Track number of participants enrolled in a defined time
                period as a result of each strategy*

            b.  *Maintain screening/enrollment log forms with
                attribution to specific strategy and reasons for
                ineligibility, or non-enrollment*

            c.  *Calculate cost of enrollment per participant*

            d.  *Survey of participants' opinions re: strengths and
                weaknesses of strategies*

        3.  *Track participant withdrawals and reasons for withdrawal*

        4.  *Rapidly implement modified or alternative plans if
            recruitment is lagging*

III. **Retention and adherence phase -- Be proactive**

     A.  *Maintain communication with referring physicians re;
         participant progress*

     B.  *Establish and maintain rapport among staff during follow-up*

         1.  *Newsletter*

         2.  *All-site teleconferences*

         3.  *Buddy system among coordinators*

         4.  *Adequate staff compensation*

         5.  *Staff recognition/awards*

         6.  *Clinic non-protocol staff recognition*

     C.  *Establish and maintain rapport and communication with
         participants*

         1.  *Identify and track attrition red flags*

             a.  *Adverse effects*

             b.  *Missed appointments*

             c.  *Frequent appointment time changes*

             d.  *Major personal or family events*

             e.  *Health deterioration*

             f.  *Loss of support system*

             g.  *Do not promise support that cannot be maintained*

         2.  *Adverse effects (AEs)*

             a.  *Inform patients as to what to expect*

             b.  *Have prepared AE management protocol*

         3.  *Maintain current contact info*

         4.  *Enlist support of participant's social network*

             a.  *Transportation*

             b.  *Encouragement*

             c.  *Agent compliance*

         5.  *Consider establishing a support group*

         6.  *Provide remuneration as budgets permit*

             a.  *Parking*

             b.  *Time lost from work*

             c.  *Transportation*

             d.  *Child care*

         7.  *Ensure pleasant clinic visits*

             a.  *Limit waiting room time*

             b.  *Coordinate assessments (e.g., Blood work, imaging,
                 etc.) with visits*

             c.  *Provide refreshments*

             d.  *Flexible scheduling*

             e.  *Toll-free numbers*

         8.  *Ensure consistent staff contact person and access to PI*

         9.  *Establish schedule for contact with patient*

         10. *Consider retention tools*

             a.  *Calendars*

             b.  *Newsletter*

             c.  *Appointment reminder cards and calls*

             d.  *Anniversary cards*

             e.  *Certificates of appreciation and appreciation*

             f.  *Tee-shirts, mugs, magnets*

             g.  *Buddy system*

             h.  *Support groups*