Clinical OperationsGlossary Term
ICH E6(R3) Section 4.4
The activities and strategies employed to identify, attract, and screen potential participants for enrollment in a clinical trial, encompassing advertising, physician referrals, database searches, and community outreach.
Patient recruitment encompasses the diverse methods and communications used to identify individuals who may be eligible for clinical trial participation and motivate them to learn more about the study opportunity. Effective recruitment balances the scientific need to enroll adequate numbers of participants within reasonable timeframes against the ethical imperative to provide accurate, non-coercive information that enables informed decision-making. Recruitment failures represent one of the most common reasons for trial delays and cost overruns.
Recruitment strategies vary based on the disease area, study design, and patient population characteristics. Traditional approaches include physician referrals within the investigator's practice, referrals from colleague physicians, medical record screening to identify potentially eligible patients, and advertising through various channels. Digital recruitment methods have expanded options significantly, enabling targeted outreach through social media, search engine marketing, patient advocacy organization partnerships, and online patient communities. Each recruitment channel has distinct advantages, costs, and regulatory considerations.
All recruitment materials and methods require IRB/IEC review and approval before implementation. Advertising must be accurate and not misleading regarding the nature of the research or potential benefits. Recruitment messaging must clearly identify the opportunity as research rather than clinical care, avoid claims of therapeutic benefit unsupported by evidence, and refrain from emphasizing payment in ways that might constitute undue inducement. The recruitment process sets expectations for potential participants and influences their understanding and trust throughout trial participation.
Multi-channel recruitment
"The recruitment strategy combined physician database screening, social media advertising targeting the patient demographic, and partnerships with three patient advocacy organizations to generate study awareness."
IRB-approved materials
"Before launching the digital recruitment campaign, the site submitted all advertisement copy, landing page content, and prescreening questionnaire to the IRB for review and approval."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
ICH E6(R3) Section 4.4
The activities and strategies employed to identify, attract, and screen potential participants for enrollment in a clinical trial, encompassing advertising, physician referrals, database searches, and community outreach.
Patient recruitment encompasses the diverse methods and communications used to identify individuals who may be eligible for clinical trial participation and motivate them to learn more about the study opportunity. Effective recruitment balances the scientific need to enroll adequate numbers of participants within reasonable timeframes against the ethical imperative to provide accurate, non-coercive information that enables informed decision-making. Recruitment failures represent one of the most common reasons for trial delays and cost overruns.
Recruitment strategies vary based on the disease area, study design, and patient population characteristics. Traditional approaches include physician referrals within the investigator's practice, referrals from colleague physicians, medical record screening to identify potentially eligible patients, and advertising through various channels. Digital recruitment methods have expanded options significantly, enabling targeted outreach through social media, search engine marketing, patient advocacy organization partnerships, and online patient communities. Each recruitment channel has distinct advantages, costs, and regulatory considerations.
All recruitment materials and methods require IRB/IEC review and approval before implementation. Advertising must be accurate and not misleading regarding the nature of the research or potential benefits. Recruitment messaging must clearly identify the opportunity as research rather than clinical care, avoid claims of therapeutic benefit unsupported by evidence, and refrain from emphasizing payment in ways that might constitute undue inducement. The recruitment process sets expectations for potential participants and influences their understanding and trust throughout trial participation.
Multi-channel recruitment
"The recruitment strategy combined physician database screening, social media advertising targeting the patient demographic, and partnerships with three patient advocacy organizations to generate study awareness."
IRB-approved materials
"Before launching the digital recruitment campaign, the site submitted all advertisement copy, landing page content, and prescreening questionnaire to the IRB for review and approval."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.