Subject Enrollment
System
Bonnie Zimmer
P1078 Training
December 2013
Topics

Terminology & Procedures

Enrollment Methods

Screening Checklist

Identification of Subsets
P1078 Training – December 2013
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PID
PID Example: 1234567b

Patient Identification Number

Also referred to as a PATID

A unique number that identifies a patient

Assigned by the site to a potential study
participant prior to enrollment

A participant keeps the same PID for all studies
and when transferred to other sites
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PID Lists

A PID list contains a listing of PID numbers

Generated by the DMC

This PID list is emailed to your site coordinator and
site data manager

New lists are generated upon request when a site
depletes their original list


Site should request list when about 50 PID
numbers remain
Lists are generated for the site, not the study
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SID Example: P10784321b
SID Number

Study Identification Number

A SID is comprised of the study number, a sequence
number, and a check digit

A unique number that signifies a successful enrollment
and if applicable a treatment regimen

A PID receives a SID upon successful enrollment

Each successful enrollment to a protocol/step
receives a SID number, including non-treatment
studies
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SID Lists

A SID list contains a mapping of SIDs to treatment
regimens for a site and study

This list is mailed to your pharmacist by the DMC, and is
used to prepare the treatment regimen for a newly
enrolled PID

Mailed at time of network protocol approval
NOTE: You should not enroll patients before the pharmacist has
received this list
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PID / SID Relationship
Study
PID
SID
P1078
110001a
P1078 1001f
P1060 (Step 1)
110001a
P1060 1029c
P1060 (Step 2)
110001a
P1060 1333b
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Subject Enrollment System

Web-based program

Verifies patient eligibility and enrolls eligible
participants to the study

Enrollment Result is displayed and emailed to the user
 If an enrollment is successful, it contains the SID number and
eligibility information
 If an enrollment is unsuccessful, the enrollment result will
contain an error message
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Eligibility Checklist

The eligibility checklist is a form in the SES that
contains a series of questions used to determine
if a participant is eligible for a specific protocol

The eligibility checklist contains questions
derived from the Inclusion & Exclusion sections
of a protocol document
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Screening Checklist

The Screening Checklist is a form in the SES that
contains a series of questions used to obtain a
screening number for a participant for a specific
protocol.

More information on the Screening Checklist will be
presented later in the presentation.
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Enrollment Methods
Eligibility checklist
completed online;
enrollment using
SES
Eligibility checklist
completed offline;
enrollment using
SES
P1078 Training – December 2013
Contact the
Randomization
Department at the
DMC
11
Enrollment Method #1
Eligibility checklist
completed online;
enrollment using
SES
Each protocol step is
shown here.
Warnings are shown
up-front.
Be sure to confirm version of the protocol.
Also confirm Eligibility
Checklist date with date
on hand-completed copy
When a question has been
successfully answered, the next
valid question becomes available for
completion, while remaining
questions are blocked.
If a previous answer is
changed, all answered
questions after that
question will be erased.
Enter date using indicated format,
mmm/dd/yyyy.
Date format does
depend on study.
PROMISE studies use
dd/mmm/yyyy format.
Time is entered using a 24-hour
clock.
The time entered here is the time
the enrollment took place.
When completing the paper copy
of the Eligibility Checklist, leave
that field blank.
Skip logic has user go to
next appropriate
question and blocks
access to questions that
are not required to be
completed
Some questions are dependent on
other questions.
This question uses the answer of the
previous question.
Identify which network
should be credited with
this enrollment.
The participant can
identify multiple
ethnicity and race
categories.
Race categories may
be site-specific.
Confirmation of Answers

Note: Be sure to double-check the answers on
the Eligibility Checklist to avoid errors in
enrollment.
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Introductory Workshop - October 2013
30
Enrollment Method #2
Eligibility checklist
completed offline;
enrollment using
SES
Saving an Eligibility Checklist
Offline

If your site has an unstable Internet connection
at times, you may want to be prepared to use
this option.

Prior to Internet connection difficulties:

Save an electronic version of the desired checklist to
your PC

Open save checklist, and scroll to end of checklist for this
option:
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Entering an Eligibility Checklist
Offline

If experiencing an unstable Internet connection:

Open saved electronic version of checklist.

Fill out the checklist offline.

Once completed, connect to the Internet and click
Enroll (at bottom of saved checklist).
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Enrollment Method #3
Contact the
Randomization
Department at
the DMC
Contact Information
User
Support
24/7
Telephone: 716-834-0900 ext. 7301
Email: rando.support@fstrf.org
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Protocol-Defined Screening
LOA #1:The Data Management Center (DMC) Screening
Program will be used for this study and will replace the
screening log. Section 4.4 (Screening Procedures) and
Appendix IV-B (Sample Informed Consent) have been
changed.
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PID number is not captured in
the screening checklist.
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Eligibility Checklist

Screening number obtained from screening
checklist entered into eligibility checklist.
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Screening Failure Forms

Complete and key a Screening Failure Form when:


Participant is not enrolled to the protocol for which a Screening
Number was obtained.
IMPAACT Screening Failure forms are accessed on the
FSTRF Portal under:

Case Report Forms > Forms Management Utility > Forms

Screening Failure form is listed in the Maternal List of Forms, but
is not in the CRF.
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Introductory Workshop - October 2013
42
Assignments for Intensive PK, PBMC
and QGIT supernatant subsets
• The subject has been assigned to intensive PK per protocol
section 9.0
The subject has been assigned to have all of the following
collected:
PBMC at entry for TB ELISPOT
PBMC at weeks 12, 44 and 48 postpartum stored for TB ELISPOT
Plasma at weeks 12, 44 and 48 postpartum stored for future
testing
QGIT supernatants at delivery and week 44 postpartum
•
Subset Assignments, continued
•
The subject has been assigned to have all of the following collected:
PBMC at entry, stored for future testing
QGIT supernatants at delivery and week 44 postpartum
• The subject has been assigned to have all of the following collected:
PBMC at entry, stored for future testing
QGIT supernatants at delivery
• The subject has been assigned to have the following collected:
QGIT supernatants at delivery
Special Note:

Each treatment will have this note:
• There is
no treatment assignment
for infants
Contact Information
User
Support
24/7
Telephone: 716-834-0900 ext. 7301
Email: rando.support@fstrf.org
P1078 Training – December 2013
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Questions?
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