Office of Human Research
Page Title
SOP No.: 603 SUBJECT ENROLLMENT AND SCREENING |
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Author: Office of Human Research |
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Effective Date: October 1, 2007 |
Supercedes document dated: N/A |
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Last Reviewed on: N/A |
Results of Review: N/A |
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This SOP pertains to: Every participant who is considered for enrollment in FDA-regulated human subject research within Thomas Jefferson University must have his/her eligibility to participate confirmed according to this procedure. |
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Responsibility for executing this SOP: Investigator and Designated Research Personnel |
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Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR) |
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR) |
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1. PURPOSE
This procedure describes the process to be followed for confirming the eligibility of participants to participate in Food and Drug Administration (FDA)-regulated human subject research.
2. GENERAL INSTRUCTIONS
The Investigator and participating Investigators are responsible for ensuring written confirmation of a participant's eligibility to be enrolled in a clinical study prior to the participant's enrollment in the clinical study.
3. SPECIFIC PROCEDURES
3.1 Preparing Subject Eligibility Documentation
- After all required regulatory authorities have approved a clinical protocol, the Investigator or should prepare a Subject Eligibility Checklist to include all inclusion/exclusion criteria listed in the protocol (See SOP 603 Attachment A). This may also be provided by the sponsor or CRO for the trial.
- The Investigator should prepare a Screening and Enrollment Log for use at the study site (See SOP 603 Attachment B). This may also be provided by the sponsor or CRO for the trial
3.2 Conducting Screening Activities
As a general rule consent must be obtained before any protocol specific screening procedures are performed on potential participants. Planned deviations from the rule must be brought to the attention of the IRB in the initial IRB submission. Unplanned or erroneous deviations from this rule must be brought to the attention of the IRB immediately.
- The Investigator should use the Screening and Enrollment Log as a running list of all potential participants screened and enrolled for the study.
- When a potential participant is identified, the Investigator should obtain all protocol-relevant medical records and information regarding the participant. This must be done in compliance with institutional requirements and HIPAA regulations.
- The Investigator should record the status of all potential participants on the Screening and Enrollment Log.
- Based on discussions with the participant and review of the medical records, the Investigator (or participating site Investigator) or his/her designee (Sub-investigator) should complete a Subject Eligibility Checklist for each potential participant.
- The Investigator will ensure that all participating investigators maintain a log to identify all screened and enrolled participants.
- Each participant screened should be given a unique identifier (i.e. initials and/ or number) depending upon the protocol. This identifier may change if the potential participant is enrolled.
- All Logs and Checklists and originals or copies of appropriate supporting documentation will be maintained in each site's study file or specific participant file, as appropriate.
3.3 Subject Numbering
- Each Investigator participating in a study must have procedures for assigning a unique participant numbering system that includes a site number and sequential subject number. Subject numbering procedures may be developed by the sponsor or CRO.
- Once a participant's eligibility to participate in the clinical study has been confirmed, the participant will be assigned the unique subject number according to the predetermined numbering system.
4. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 50.20 |
General requirements for informed consent |
21 CFR 56.109 |
IRB review of research |
21 CFR 312.60 |
General responsibilities of investigators |
21 CFR 312.62 |
Investigator recordkeeping and record retention |
FDA Information Sheets, October 1998 |
Screening Tests Prior to Study Enrollment and Recruiting Study Subjects |
May 1997 |
International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline |
5. REFERENCES TO OTHER APPLICABLE SOPs
GA-102 |
Responsibilities of the Research Team |
SS-201 |
Assessing Protocol Feasibility |
SS-204 |
Protocol Start-Up |
PM-303 |
Regulatory Files and Subject Records |
SM-401 |
Informed Consent Development and Implementation |
SM-403 |
Subject Management While on Study |
6. ATTACHMENTS
A. Subject Eligibility Checklist
B. Screening and Enrollment Log
7. DEFINITIONS AND GLOSSARY
The following definitions from the International Conference on Harmonisation, Good Clinical Practice: Consolidated Guideline apply to this SOP.
Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.
Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
