SOP FORM

Document Sample
SOP FORM Powered By Docstoc
					SOP FORM


Standard Operating Procedure Title:             SEA Infectious Disease Clinical
Participant Screening and Enrollment -          Research Network
Eligibility Determination
                                                New Issue: include version number and
                                                date SOP is written
                                                Supersedes version: N/A
Site Name and Number:                           Effective Date: include date the SOP
Include study site name and number              becomes effective
                                                Approved by: include name(s) of
                                                individuals who have reviewed and approved
                                                this SOP Site PI; CTSS?

I.     PURPOSE

This Standard Operating Procedure (SOP) describes how participant eligibility will be
determined at this research site.

II.    APPLIES TO
This SOP applies to all staff members at this study site delegated by the Investigator of Record
to conduct screening and enrollment procedures, and confirm participant eligibility for the study
as documented on the Delegation of Duties Log.


III.   RESPONSIBILITIES
Study staff members delegated by the Investigator of Record to conduct the eligibility
determination process for the study, and to confirm eligibility determination are responsible for
understanding and following this SOP.
The Investigator of Record has ultimate responsibility for ensuring that all applicable study staff
members follow this SOP, and for ensuring that only participants who meet the protocol-specific
eligibility criteria are enrolled in the study.
It is the responsibility of each study staff member who takes part in the screening and
enrollment process to fully understand the study eligibility criteria and to not enroll a participant
who is ineligible.


IV.    PROCEDURES

       A. SCREENING PERIOD
       The screening period for the High vs. Standard Dose Oseltamivir in Influenza Study (The
       Study) may take several days. Day Zero is counted as the day on which the
       prospective participant or legally authorized representative signs or marks The Study
       informed consent. During the screening period, the prospective participant’s eligibility for
       participation in The Study will be assessed per The Study protocol-specified inclusion
       and exclusion criteria in Section 3.7 of The Study Protocol [Version 4.0 dated
       23,October, 2006]


                                              Page 1 of 4
        1) Screening Evaluation and Procedures
                 Review the Screening Criteria Checklist found in Figure 3-1 of the
                  Study Manual to determine if the participant meets criteria for
                  screening.
                 If the potential study participant meets screening criteria, they must be
                  consented and sign the informed consent form before any screening
                  procedures are initiated. Please refer to the SOP for Informed
                  Consent for a description of the procedure.
                 If the participant agrees to be screened, a participant number will be
                  assigned and the participant’s information will be entered into the
                  Master Log.
                 Screening evaluations and procedure are described in Section 4 of
                  The Study protocol [Version 4.0 dated 23 October, 2007].
                 Review the Screening Visit Checklist found in Figure3-2 of the Study
                  Manual to ensure all screening procedures have been completed.
                 If a prospective study participant is found to be ineligible, the
                  screening evaluations will be stopped. The patient or legally
                  authorized representative will be informed that he/she is not eligible to
                  join the study and the FINAL case report form will be completed.




B. VERIFICATION OF ELIGIBILITY CRITERIA
      Once screening evaluations have been completed, and all test results have been
       received, the designated staff member (usually the Study Nurse) is responsible
       for reviewing all information pertinent to the prospective participant’s eligibility
       status (all chart notes, checklists, laboratory results and information obtained via
       medical examinations and interview). The staff member will then record on the
       chart note the prospective participant’s current eligibility status.
      Once screening evaluations have been completed, and all test results have been
       received, the designated staff member (usually the Study Nurse) will review all
       documents as stated above, as well as the screening evaluation documentation.
       If the staff member determines the prospective participant to be eligible, then the
       Study Coordinator will review the documents as a check. If the Study
       Coordinator was the initial reviewer of the study documents, and finds the
       prospective participant to be eligible, then the Study Nurse will review the
       documents as a check.
      If the prospective participant is found to be ineligible, the patient or legally
       authorized representative will be informed that he/she is not eligible to join the
       study and the FINAL case report form will be completed..
      If both the Study Nurse and Study Coordinator agree on the eligibility status of
       the prospective participant, then they will call one of the investigators for a final
       clinical review of the prospective participant’s eligibility status.



                                     Page 2 of 4
              If a study investigator finds the prospective participant to be eligible as well, then
               the prospective participant or legally authorized representative will be informed of
               his/her status. If they are still interested in enrolling, then study staff may begin
               the process of randomizing the participant into The Study.


Study Enrollment Procedures
              Research staff will provide informed consent for the study. If the participant
               agrees to participate in the study the participant or legally authorized
               representative will be asked to sign and date on the study enrollment informed
               consent form. This procedure will be performed in accordance with the SOP for
               Informed Consent.
              After the study consent form is signed the participant will be randomized to a
               study drug treatment. If the participant is not already hospitalized they will be
               admitted to the hospital
              Research staff will complete on the Inclusion Criteria and Exclusion Criteria case
               report forms.
              Enrollment procedures will be conducted as described in Section 6 of The Study
               protocol [Version 4.0 dated 23 October, 2007].
              The remaining participant information will be entered into the Master Log
              Research staff will complete the following case report forms: Enrollment History,
               Enrollment Physical Exam, and Enrollment Laboratory Tests.


DEFINITIONS

Legally authorized representative: xxx

SOP: Standard Operating Procedure

The Study: High vs. Standard Dose Oseltamivir in Influenza Study


APPENDICES
There are no appendices attached to this Standard Operating Procedure

REFERENCES
High vs. Standard Dose Oseltamivir in Influenza Study protocol [Version 4.0 dated 23 October,
2007]
SOP for Informed Consent
Figure 3-1 of the Study Manual for High vs. Standard Dose Oseltamivir in Influenza Study :
Screening Criteria Checklist
Figure 3-2 of the Study Manual for High vs. Standard Dose Oseltamivir in Influenza Study:
Screening Visit Checklists




                                             Page 3 of 4
Figure 3-3 of the Study Manual for High vs. Standard Dose Oseltamivir in Influenza Study;
Sample Master Log
Figure 3-4 of the Study Manual for High vs. Standard Dose Oseltamivir in Influenza Study:
Participant Contact Sheet
Figure 3-5 of the Study Manual for High vs. Standard Dose Oseltamivir in Influenza Study:
Enrollment Checklist

APPROVAL
This SOP must be approved by the study site Principal Investigator and by the Clinical Trials
Support Specialist who is supporting this study site.


Author                                                   Date


Name and Title                                           Date


Name and Title                                           Date




                                           Page 4 of 4

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:4
posted:9/15/2011
language:English
pages:4