North Shore LIJ Health System, Inc s1

North Shore – LIJ Health System, Inc.

SOP TITLE: RECRUITMENT AND RETENTION OF SUBJECTS

SOP #:

Approval Date:

Site Implementation Date: Prepared by:

Last Revised:

Effective Date:

OBJECTIVE:  The objective of this Standard Operating Procedure (SOP) is to describe the methods for the recruitment of study subjects for clinical studies at the clinical trial site.

RESPONSIBILITIES:  The Investigator is responsible for proper recruitment of study subjects during a clinical study. The Investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period (ICH 4.2.1).  The Clinical Research Coordinator is responsible for interactions with the study subject and for collecting accurate and complete clinical trial data during the recruitment and screening process.

PROCEDURES:

Recruitment Plan  A recruitment plan based on methods such as ones listed on the sample Recruitment Plan Worksheet, will be developed for each study.

 The Clinical Research Coordinator will develop a study-specific recruitment plan, seeking assistance from the Clinical Research Service Recruitment Core as needed.

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 The PI will review the study-specific recruitment plan to assess the potential effectiveness of the recruitment strategy before the start of the study, and periodically throughout the study.

Study Subject Recruitment and Screening Effective and efficient screening of potential study subjects for a protocol begins with a system of screening.

Screening for potential participants:  The Clinical Research Coordinator designs a screening form to assess a potential study’s subjects appropriateness for participation in a particular clinical trial. The screening form is used to screen each potential study subject to ensure consistent and accurate screening amongst the research team. Once a potential participant is identified, a telephone screen may be conducted.  The Clinical Research Coordinator will reach-out to the Clinical Research Service Recruitment Core and/or other research resource providers to develop a streamlined way to electronically screen for potential subjects within the health system.  If electronic health records (not obtained from the study/treating team) will be reviewed for patient-specific direct recruitment, IRB review and approval will be obtained prior to obtaining the lists.

Screening Logs:  A log is used to maintain screening information on each study subject screened, how much of the screening procedure the study subject completed, and whether the study subject qualified and entered the study.  A record of when informed consent was administered to each study subject is included in the log. Informed consent is signed and dated by each study subject BEFORE any study related activities are conducted.

Informed Consent:

 The Institutional Review Board (IRB) approved informed consent form should be available for review with the potential study subject before the potential study subject enters the study. Please see SOP on Informed Consent.

Subject Recruitment Materials:  Study personnel check subject recruitment methods and materials are the current approved version as required by the IRB prior to use.

Subject Retention: The relationships that the research team builds with the subjects may be the most important factor in continued participation; therefore, the following will be incorporated as feasible and appropriate:  take notes on subject’s interests and ask about it at follow-up visits,  provide helpful information about the disease and resources at the health system,  provide an appreciation package,  gather the team for a proper goodbye,  use of debit cards for visit compensation,  Make-it-Right Cards for service recovery, and  provide certificate of participation when their participation is over.

REFERENCE NSLIJHS Policy GR089: Informed Consent and Recruitment for Human Subject Research

Author: Date: ____/____/____

Approved: Date: ____/____/____

SAMPLE Recruitment Plan Worksheet “In order to be considered effective, a recruitment strategy must demonstrate a balance between response to recruitment, retention, and economics.” (A. D. Galbreath, et. al. 2008 ScienceDirect) Method Recruitments Existing Normal Affected Affected Adult -unable to Pediatric Vulnerable Hispanic Black Asian Records/ Subjects and rare consent form population population1 population population samples disease self Active Chart/lab reviews x x x x x EMR review x x x x x Billing records x x x x x Direct contact by PI x x X x x x x x (NOK/Other) Direct contact by Coord. x x X x x x x x (NOK/Other) Referral from physician x x x Recruitment Registry x x x x x contact:  E-mail  Online form  Phone  Letter Phone call x x x X x x x x x (NOK/Other) Mail x x x x x x X X E-mail X x x x x x x x Community outreach: x x x x x x x  Participate in support groups  Present useful information at community events

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Method Recruitments Existing Normal Affected Affected Adult -unable to Pediatric Vulnerable Hispanic Black Asian Records/ Subjects and rare consent form population population1 population population samples disease self Passive N/A External web ad x x x x Health System general X x x x x x x website listing  Online application ClinicalTrials.gov or X x x x x x x x other internet listings Video tape, radio, x x x x x x x television Brochures/pamphlets X x x x x x x Postcards X x x x x Newspaper2 x x x x Press release3 x x x x External flyers X x x x x x External posters x x x x x Health System X x x x x x x x publications (i.e. Vitality, Focus on Research, & Focus on Health) Foundations: x x x x x x  Ads in newsletters, e-mails, social media, etc.  Participate in events, talks and other educational initiatives  Attend disease- specific meeting External lectures X x x x X x X External collaborators x x X x x x

Method Recruitments Existing Normal Affected Affected Adult -unable to Pediatric Vulnerable Hispanic Black Asian Records/ Subjects and rare consent form population population1 population population samples disease self Facebook page? Search? x Twitter notice of study x Craigslist listing of study X Physician to physician x x x x letter Targeted patient letter x x x x x Internal flyers X x x x Internal posters x x x x x x x Internal Ads (i.e. E-News X x x x x x x x x Bulletin, Healthport, E- Newsletter to physicians) Internal X x x x x x x x x Communication:  Plug at department Reminders at meetings  Educate department on study  Provide inclusion/exclusion criteria and/or contact cards Word of mouth X x x x x x x x

Incentives N/A Payment to subjects x (cash/non-cash) Reimbursements x x x x x x x x Small completion x x x x x x bonuses

Method Recruitments Existing Normal Affected Affected Adult -unable to Pediatric Vulnerable Hispanic Black Asian Records/ Subjects and rare consent form population population1 population population samples disease self Retention Ideas: N/A Take notes on subject’s x x x x x x x x x interests and ask about it at the next visit Postcard reminder with x x x x x x x x tear-off for a friend Certificate of x x x x x x x x participation Appreciation package x x x x x x x x x Proper goodbye x x x x x x x x x Use of ClinCards x x x x x x x x x Make-it-Right Cards for x x x x x x x x x service recovery Provide helpful x x x x x x x x information about the disease and resources at the health system

Other recruitment and retention methods that will be used:

N/A 1 Includes employees 2 Needs marketing approval 3 Work with public relations NOK= Next of kin

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