28 January, 2026
Author : Dr Vijaykumar Gawali

Topic : ROLE OF A CRC IN PATIENT RECRUITMENT

Definition & Importance

Patient recruitment is the process of identifying, screening, and enrolling eligible participants into a clinical trial following ICH-GCP, protocol requirements, and EC-approved procedures.

For a CRC, recruitment is one of the most critical responsibilities because delays in recruitment directly impact study timelines and site performance.

Responsibilities of the CRC in Recruitment

A CRC plays a central, operational, and compliance-focused role in recruitment:

A. Pre-Recruitment Activities (Before EC Approval)

These activities are allowed only if no direct patient contact occurs:

Feasibility Assessment

• Review hospital patient load for the study indication.
• Extract data from:
• HIS (Hospital Information System)
• OPD/IPD registers
• Specialty departmental registries
• Diagnostic center data
• Prepare a potential patient pool report.

Drafting Recruitment Strategy for EC Submission
CRC assists the PI in drafting:

• In-house recruitment methods (posters, standees, brochures)
• Multimedia recruitment (hospital website, sms system, whatsapp broadcast per policy)
• Newspaper and print media ads
• Referral pathway from internal departments

➤ All recruitment materials must be EC-approved before use.

B. Recruitment Activities After EC Approval

OPD/IPD Screening with the PI
CRC sits in OPD with the investigator to:

• identify potentially eligible patients
• verify inclusion/exclusion criteria
• maintain pre-screening log
• prepare patients for detailed screening

Explaining the Study
CRC supports the PI by:

• arranging a private room for discussion
• providing EC-approved ICF
• answering procedural questions
• scheduling screening visits

Documenting All Recruitment Activity

• Pre-screening log
• Screening log
• Referral log
• Advertising/IEC-approved materials
• Summary of daily OPD screening activity

Step-by-Step Recruitment Workflow

Step 1: Create Patient Pre-Screening List

From HIS/departmental registries:

• Retrieve diagnosis codes
• Filter appropriate age groups
• Prepare list for PI review

Step 2: OPD/Clinic Screening

• Attend OPD with PI
• Match patients to eligibility criteria
• Document in pre-screening log

Step 3: Explain Study (after PI introduces the study)

• Ensure privacy
• Provide ICF
• Use non-coercive language
• Answer questions

Step 4: Document Decision

• Consented? → Proceed to screening
• Not interested? → Record reason in pre-screen log

Compliance Requirements

• No patient may be contacted before EC approval.
• No unapproved recruitment materials may be used.
• No coercion, pressure, or misleading information.
• Protect patient confidentiality at all times.