Pull List Specifications

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Pull List Application: Control reselection

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Design Specification
Version Date Author Version: 1.1
Comments Sections Circulated Purpose
affected to:
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Author:
Shelley Tworoger
Signature: Date:

Author: Shelly Tworoger Page 1 of 11 Date: 24/12/2008

Pull List Specifications

Distribution List
Company Entity Recipient Name Action

Shelley Tworoger

Mark Magid
Helena Judge Ellis
Rachel DePasquale
Jeanne Sparrow
Eric Rimm
Sue Hankinson

Author: Shelly Tworoger Page 2 of 11 Date: 24/12/2008

Pull List Specifications

Contents

1. Introduction 4
1.1 Purpose of document................................................................................4
1.2 Background................................................................................................4
1.3 Scope of the specification.........................................................................4
1.4 Input 4
1.5 Output 4
1.6 Glossary of Terms and Definitions.............................................................5
1.7 Contacts7

2. Functional Overview.................................................................................8
2.1 Business Objectives..................................................................................8
2.2 Functional Diagram...................................................................................8
2.3 Design Mock-up.........................................................................................9
2.4 Requirements............................................................................................9
2.5 Non-Functional Requiremets...................................................................10
2.6 Outstanding Issues..................................................................................10

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1.Introduction

1.1Purpose of document
The purpose of this document is to outline the specifications for dealing participants
who have to be removed from the dataset and a replacement used (often called a
reselection) that occurs after the pull list has been generated and samples pulled (see
Pull List specifications). Occasionally in a new project, controls for some reason may
have to be reslected in a case-control study or participants replaced in a cohort study;
this can occur for a number of reasons including being unable to locate an
appropriate specimen (see Missing Vial Update specs) or a change in the programs
used to select the participants. The purpose of this secondary application is to allow
an authorized blood programmer to update the sending list and pull lists, as well as
allow the blood lab to determine a freezer location for the new participant.

1.2Background
When an participant has to be reselected, the sending and pull lists and the freezer
database must then be updated to correct the error and note which tube was actually
pulled. Future lists (e.g. sort lists, box lists) must reflect the change.

1.3Scope of the specification

The concern of this application and this specification are to allow an authorized blood
programmer to correct problems with the sending and other lists and to allow the blood
lab to pull a vial for the new participant and put it in with the other pulled vials.

1.4Input
All inputs will be entered or uploaded by the user into the screen described below.

1.5Output
Output will include or two pieces of information. The first piece will be output every
time and will include a verification that the sending and pull lists have been correctly
updated. The second piece of information will be in the pull list format described in the
Pull List Specifications and will include output such as freezer, rack, box, and spot of
the new vial to be pulled.

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1.6Glossary of Terms and Definitions

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Term Definition
Reselection This occurs when for some reason a participant who was selected
for a project (e.g. a control) needs to be excluded from the data set
and a replacement added. The blood programmers will be
responsible for choosing the new participant and uploading the
relevant information to Healthtrack.
Vial A tube filled with biological specimen to be used in an assay request
or as part of a pull list.
Pull List General term for the functionality that generates the all the vial lists
used to pull biospecimens from the freezer for a set of assay
requests.
STAGES OF PULL
LIST
Initialization Entering the initial data for a pull list, choosing assay requests,
setting parameters. Includes making decisions about appropriate
parameter settings and changing those parameters to get the best
list.
Active Approved and finalized the pull list, all final parameter settings
selected. Vials are reserved in the database. Pull list has been
generated and blood lab personnel are actively pulling samples out
of the freezer. Includes updating the freezer file when an incorrect
tube is found, getting new locations of alternate vials, and noting
what new subvials have been created.
Completed and After all vials have been pulled for a particular pull list, finalized
Updated updates are made to the freezer file, including removal of original
and subvials, addition of newly made subvials. Also includes final
update to the sub-sending list that notes which vials were sent for
which assay requests.
TYPES OF LISTS IN
PULL LIST
FUNCTIONALITY
Original vial list List of original vials, separated by vial type (i.e. vial size), with
locations in the freezer and other information (see appendix) to be
used for pulling vials for a Pull List. Generated by the pull list
functionality.
Subvial list List of subvials, separated by assay request, with locations in the
freezer and other information (see appendix) to be used for pulling
vials for a Pull List. Generated by the pull list functionality.
Index number A sequential set of numbers, beginning at 1, assigned to each vial in
a pull list overall all original and sub-vial lists. In other words, no
number is repeated and this acts as a unique identifier within pull
list.
Unique Vial ID ID number assigned by oracle for every vial handled in a pull list or
other project
Participant ID The ID number assigned to a participant when he or she entered the
study
Pull list ID ID number assigned by oracle for each Pull List generated for a set
of assay requests.
Sub-sending list A list of all potential IDs/vials in an assay request. Notes what vial

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1.7Contacts
Name Job Title/ Position/ Signoff Telephone E-mail
Role
Shelley Project Lead 5-2087 nhsst@channing.ha
Tworoger rvard.edu
Mark Magid Project 5-0074 mgmagi@hotmail.c
Development om
Helena Lab Manager 617-732-5781 nhhje@channing.ha
Judge Ellis rvard.edu
End User
Rachel Lab Manager hprap@channing.h
DePasquale arvard.edu
End User
Jeanne Data Manager 5-4220 nhjms@channing.h
Sparrow arvard.edu
Rakesh

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2.Functional Overview
2.1Business Objectives
2.2Functional Diagram
Enter Assay Request
Request
*if replace/delete participants
**if need to change parameters
***if a vial is
missing in
freezer, pull
alternate vial if
one exists, if
not remove from
list + any matched
controls if a case
-Aliquot sort list, separated
by original vial volume
-Generates labels for newly
aliquoted tubes
Actual aliquots recorded
in healthtrack
New aliquots into
sending box
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Enter Assay Request Enter Assay
Conduct tally to find cases/controls
that may need to be removed,
update sending lists.
Create Pull List Request
* **
See Intermediate Results (Put “hold” on potential vials)
Finalize Pull List
Generate Freezer Pull List(s)
Generate Pull Box Labels
(Blood Lab RA Pulls Tubes***)
Generate Sub-Sending List by Assay Request
to note which ID’s will actually be set.
Sorting Lists Information Defined (e.g. Box size, aliquot volumes)
Sort Lists Generated
Final sort list, separate by assay
request , notes where subvials are
placed into sending boxes. Make
QC labels
Add QCS w/ labels that have fake ID’s
Put subvials into
sending box
Computer generates a box list/ASCII file
Double check, give sub-sending list to programmer
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2.3Design Mock-up
N/A

2.4Requirements
Below are the fields and actions that should be included on the Missing Vial Update user-
interface:

* Pull list ID: <Single selection pull down list of Active (pulling) Pull List IDs>. Based on this
selection, the corresponding information about the cohort, collection, sample type, endpoint,
and all assay request IDs in the pull list will be displayed.

OR

*Assay Request ID (Same as above)

* List of replacement IDs:

-If the user wants to replace some IDs with other IDs, they will use this box to either cut
and paste the list or upload a file with the list.
-The list will be comprised of 2 or 3 columns depending on the type of study:
* Old participant ID that is to be removed from all the sending lists in the
selected pull list.
* New participant ID that will replace the removed ID (for all sending lists in the
selected pull list.
*If a case-control study, the Match ID.

* List of additional IDs:

- If the user wants to add new IDs, then they will use this box to either cut
and paste the list or upload a file with the list.
- The list will be comprised of 1 column, ID(s) to be added.

* List of deleted IDs:

- If the user wants to delete IDs without replacement, then they will use this box
to either cut and paste the list or upload a file with the list.
- The list will be comprised of 1 column, ID(s) to be deleted.

* Buttons:
1. Update sending list: This entails updating all of the sending lists used in the specified pull
list by removing the old ID(s) and/or adding the new ID(s). The “sub-sending list” (described
later) also will be updated by denoting the old ID as not sent and the new ID as the
replacement.

2. Generate pull list of the new ID: This entails updating the original vial and subvial lists for
the specified pull list. Healthtrack will identify the best vial(s) to be pulled for the new
participant ID(s) based on the vial priority specified in the pull list. The lab end-user will then
be able to print out an updated list with the new vials highlighted.

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2.5Non-Functional Requiremets
Research Assistants and Lab Technicians generally have not used oracle databases.
The user interface of this and any part of Htrack needs to accommodate for their skill
set and ensure usability by making the product as easy to use for non-technical
people as possible.

2.6Outstanding Issues
None.

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