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  In-Life protocol analysis system procedures

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National Toxicology Program Support

In-Life PAS Procedures

National Toxicology Program Support

In-Life PAS Procedures

Prepared for: National Institute of Environmental Health Sciences

> Research Triangle Park, NC 27709

Contract no.: 273-95-I-0012

Prepared by: Technology Planning & Management Corporation

Imperial Center

Canterbury Hall, Suite 310

4815 Emperor Boulevard

Durham, NC 27703

Revision Summary

  ------------ ------------ ------------ -------------------------------------
  **Date       **Document   **Revision   **Reason for Revision**
  Released**   Number**     Level**      

  04/99        LP-1013      4.0          Update for VAX to HAZEL and ISN to
                                         TPMC references. Place manual in new
                                         template. Update tables.

  11/94        LP-1013      3.0          Menu updates and procedure changes.

  05/93        LP-1013      2.0          Address changes in the procedures
                                         liaisons use to operate PEX, the
                                         interactive maintenance system for
                                         PAS, since the last release of this
                                         document.

  12/88        LP-1013      1.0          New
  ------------ ------------ ------------ -------------------------------------

Table of Contents

Revision Summary

Table of Contents

Chapter 1

Introduction

Overview

Figure 1, Overview of In-Life PAS Procedures

Chapter 2

In-Life PEX Procedures

Receive and Verify Manual Forms

Enter PEX Data

Enter Data Manually

Figure 1, TDMS Main Menu

Figure 2, PAS Main Menu

Figure 3, PEX EIS Operation Selection Menu

Figure 4, PEX EIS Segment Selection Menu

Enter Weighed Items Range Validation

Figure 5, Segment Operation Selection Menu

Figure 6, Weighed Items Range Validation

Enter Loading Requirements and Weight Validation

Figure 7, Loading Requirements and Weight Validation

Enter Selected Clinical Observations

Figure 8, Selected Clinical Observations

Figure 9, Clinical Observations

Figure 10, Selected Clinical Observations (MOD)

Figure 11, Selected Sites (MOD)

Figure 12, Selected Sizes (MOD)

Figure 13, Reasons for Removal (MOD)

Enter Animal Removal Actions

Figure 14, Removal Actions (ADD)

Enter Rack-Cage Configuration

Figure 15, Rack-Cage (ADD)

Enter Cage Census Definition

Figure 16, Census Definition (ADD)

Enter Preparation Definition

Figure 17, Preparation Definition (ADD)

Enter Procedure Definition

Figure 18, Procedure Definition (ADD)

Enter Treatment Definition

Figure 19, Treatment Definition (ADD)

Enter Facility/Chemical Linkage

Figure 20, Facility /Chemical Linkage Information (ADD)

Figure 21, Facility/Chemical Linkage Information (cont..)

Enter Responsible Parties

Figure 22, Responsible Parties (ADD)

Enter Balance Calibration Weights

Figure 23, Balance Calibration Weights (ADD) screen

File the Forms

Copy PEX Segments from Previous Studies

Figure 24, PEX EIS Copy Selection List screen

Figure 25, PEX EIS Operation Selection Menu

Figure 26, PEX EIS Copy Selection List (Error)

Modify PEX Segments

Figure 27, PEX EIS Segment Selection Menu

Chapter 3

PAS Validation Report Procedures

Generate the PAS Validation Report

Figure 28, PAS Validation Report Request- EIS screen

Total Validation Set, Less Schedules

Individual Reports

Verify the PAS Validation Report

Certify PAS Data

Chapter 4

In-Life Download Procedures

Create In-Life Download Files

Figure 29, Select Transaction Type screen

Modify PAS Data After In-Life Download

Perform a Partial Download of Modified Transactions

Figure 30, Select EIS Transactions To Download

Appendix A A

TDMS Tables A

Facility Table A

Action Table A

Weight Table A

Test Type Table A

Dose Route Table A

Animal Supplier Table A

Strain Table A

Growth Weight Table A

Appendix B B

PEX Checklist B

Appendix C C

TDMS Standard Clinical Observations C

General C

Behavior C

Lesions C

Site of Application C

Selected Sites C

Selected Sizes C

Removal Reasons C

Introduction

The purpose of this document is to provide Toxicology Data Management
System (TDMS) liaison personnel with instructions for using PEX the
interactive maintenance system, to initiate and define new Toxicology
Data Management Systems (TDMS) studies and to modify existing study
definitions.

This document will describe how to add a study to the Protocol Analysis
System (PAS) database and how to use the PAS download system to transfer
TDMS protocol data from the mainframe to a lab's on-site microcomputer.

# Overview

PAS consists of two distinct subsystems. The Experiment Information
System (EIS) is used to define the protocols for in-life data
collection. The Post-Experiment Information System (PEIS) is used to
define the protocols for pathology data collection. This document covers
only the in-life procedures.

An experiment's protocol provides a schedule for activities and data
collection for the duration of an experiment. Figure 1, on the next
page, provides an overview of liaison actions to initiate an EIS
experiment.

Before a laboratory begins a new study, the data administrator submits a
set of manual forms to the site liaison. The information on this set of
forms is derived from the experiment's official protocol. The codes
entered on the manual forms come from the TDMS Tables and, therefore,
are standard components. In-Life PAS components include the following:

-   Dose concentrations

-   Treatment schedules

-   Data collection schedules

-   Animal census data

After verifying that the manual forms are complete, the liaison creates
protocol definition files using PEX. The liaison generates and prints
the Validation Report to verify data-entry accuracy.

The liaison transmits the Validation Report to the laboratory. The data
administrator reviews and approves the report.

Finally, the liaison downloads the files from the VAX to the on-site
laboratory microcomputer. The downloaded files control screen displays
that prompt animal room technicians to perform experiment tasks and
collect data.

![](media/image1.emf)

Figure 1, Overview of In-Life PAS Procedures

In-Life PEX Procedures

PEX is the interactive maintenance system for PAS.

The liaison uses PEX to indicate and define new Toxicology Data
Management System (TDMS) studies and to modify existing study
definitions. Normally, PAS data must be entered and modified five
working days before the start of a study. However, if the site liaison
receives the forms fewer than eight days before the start of a study,
the data must be entered and verified within three working days.

# Receive and Verify Manual Forms

Follow these procedures to receive and verify the information on the PAS
manual forms:

1.  Place the forms in the order outlined in *Appendix C, PEX
    Checklist*. Attach the checklist to the top of the packet.

2.  Make sure the following forms are included in the packet and contain
    all necessary information:

-   Weighed Items Range Validation

-   Loading Requirements and Weight Validation

-   Selected Clinical Observations

-   Animal Removal Actions

-   Rack-Cage Configuration

-   Census Definition

-   Preparation Definition

-   Procedure Definition

-   Treatment Definition

-   Facility/Chemical Linkage Definition

-   Responsible Parties

-   Balance Calibration

3.  Make sure the codes on the forms are valid (refer to *Appendix A,
    TDMS Tables*). Screen the forms for code errors, conflicting
    actions, and incorrect number of animals in census.

4.  Determine the severity of any errors that you find. An example of a
    minor error is missing or incorrect information. A missing form is
    considered a major error. Do one of the following based on your
    determination:

-   If the error is **minor**, call the data administrator to confirm
    the error and get directions to correct it. On the manual from, note
    the following: the correction, the data administrator at the lab who
    initiated the correction, your initials, and the date. Ask the data
    administrator to submit a new manual form to reflect the correction.

-   If the error is **major**, call the data administrator and request
    the missing form.

NOTE

> Corrected forms submitted by the data administrator must carry an
> authorized signature and the date of the correction. In addition, some
> labs may stamp the forms with a CORRECTION stamp. File the corrected
> form with the original manual form in the experiment file.

5.  To simplify data entry and reduce the possibility of error, PEX
    allows you to copy segments from one study to another.

Before you begin data entry, identify a previously completed study that
is very similar to the new study. Often, the studies a lab conducts are
very similar, so you should first look at previous studies conducted by
the same laboratory facility. Also, check the Number of Treatment
Groups, Species, and Study Type segments in previous studies to identify
a study that could be useful for copying segments.

Identify the sections of the previous study that can be copied to the
new study. Make a note of the previous study's number in the space
provided on the PEX Checklist (the PEX Checklist appears in Appendix C).

The details of this procedure are described later in this chapter in the
"Copy PEX Segments form Previous Studies."

6.  As you complete data entry for each segment, put your initials and
    the date entered by the name of the segment on the PEX Checklist.

# Enter PEX Data

PEX provides two methods of data entry. You may enter data manually, one
field at a time, or copy segments from an existing study. When entering
data into a new study, you will probably want to utilize both data entry
methods.

While performing manual data entry, if you completely fill a field, the
cursor automatically moves to the next field. Otherwise, use \<TAB\> to
move to the next field, \<RETURN\> to move to the next line, or the
arrow keys to move to any field on the screen.

If you enter data incorrectly, use \<TAB\>, \<RETURN\>, or the arrow
keys to move back to the field you wish to correct. Type the correct
data over the incorrect data.

Once the data is entered correctly, press the appropriate GOLD-KEY
combination, as indicated on the bottom of the screen.

## Enter Data Manually

Follow the procedures in this section to manually enter PEX data.

**Register the New Study**

Follow these steps to register the new study:

7.  At the prompt, type \@TDMS. The TDMS Main Menu appears. See Figure 1
    on the next page.

8.  ![](media/image2.emf){width="5.495833333333334in"
    height="3.013888888888889in"}

Figure 1, TDMS Main Menu

9.  At the Please enter the NUMBER of your choice prompt, type a 1
    (Protocol Analysis System).

10. Press \<ENTER\> on the numeric keypad to make selections. The PAS
    Main Menu appears:

11. ![](media/image3.emf){width="5.495138888888889in"
    height="3.1243055555555554in"}

Figure 2, PAS Main Menu

12. At the Enter Selection Code prompt, type PE (PEX-EIS). Press
    \<ENTER\>. The PEX-EIS Operation Selection Menu appears:

13. ![](media/image4.emf){width="5.497916666666667in"
    height="3.417361111111111in"}

Figure 3, PEX EIS Operation Selection Menu

14. At the Please enter the NUMBER of your choice prompt, type a 1
    (Register New Experiment).

15. Type in the nine-digit study number. The following message appears:

16. The Study number has been registered in the master file.

17. At the Please enter the NUMBER of your choice prompt on the PEX-EIS
    Operation Selection Menu, type a 2 (Modify Experiment). Press
    \<ENTER\>. The PEX-EIS Segment Selection Menu appears:

18. ![](media/image5.emf){width="5.497916666666667in"
    height="2.959722222222222in"}

Figure 4, PEX EIS Segment Selection Menu

## Enter Weighed Items Range Validation

Follow these steps to enter weighed items range validation information:

19. At the Enter your selection: prompt on the PEX-EIS Segment Selection
    Menu, type a 1 (Weighed Items Range Validation). Press \<ENTER\>.
    The Segment Operation Selection Menu appears:

![](media/image6.emf)

Figure 5, Segment Operation Selection Menu

20. At the Enter your Selected Operation: prompt, type a 1 (ADD
    Segment). Press \<ENTER\>.

21. The Weighed Items Range Validation screen appears:

22. ![](media/image7.emf){width="5.498611111111111in"
    height="2.967361111111111in"}

Figure 6, Weighed Items Range Validation

23. At the Weighed group identification code prompt, type a 1. Enter the
    information in the Item identifier and Weight fields exactly as it
    appears on the corresponding manual forms.

NOTE

> If the manual form doesn't specify minimum/maximum bottle or feeder
> weights, type a 1 in the Weighed group identification code field.
> Leave the rest of the screen blank. Also, if there is more than one
> weight group on the manual forms, be sure to enter both of them.

24. Press G-3 to save the segment. The following message appears:

25. The segment has been written to the database. Hit 'ENTER'.

26. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
    Figure 5 on page 7.

27. At the Enter you selected operation: prompt, type a 6 (Return to
    Segment Selection Menu). Press \<ENTER\>. The PEX-EIS Segment
    Selection Menu appears. See Figure 4 on page 7.

28. As you complete data entry for each segment, put your initials and
    the date in the appropriate spaces provided on the PEX Checklist.

## Enter Loading Requirements and Weight Validation

Follow these steps to enter load requirements and weight validation
information:

29. At the Enter your selection: prompt on the PEX EIS Segment Selection
    Menu, type a 2 (Loading Requirements and Weight Validation). Press
    \<ENTER\>. The Segment OPERATION Selection Menu appears.

30. At the Enter your Selected Operation prompt, type a 1 (ADD Segment).
    Press \<ENTER\>. The Loading Requirements and Weight Validation
    screen appears:

31. ![](media/image8.emf){width="5.495833333333334in"
    height="3.0236111111111112in"}

Figure 7, Loading Requirements and Weight Validation

32. Enter the data exactly as it appears on the Loading Requirements and
    Weight Validation manual form.

NOTE

> Line 4 (Substrain Code) and line 5 (Class Code) are always 1
> (non-applicable). The following fields are no longed on the PAS forms;
> always leave these fields blank: Desired Age of Animals When Started
> on test, Low Allocation Weight Range, High Allocation Weight Range,
> Percentage of Allowable Weight Deviation While on Test.

33. Press G-4 to save the segment. The following message appears at the
    top of the screen:

34. This segment has been written to the database. Hit 'ENTER'.

35. Press ENTER. A blank Loading Requirements and Weight Validation
    screen appears. Add the next segment.

NOTE

> If there are males and females; you will complete this screen twice.

36. Continue to enter data and save the individual segments.

37. Press G-3. The following message appears at the top of the screen:

38. This segment has been written to the database. Hit 'ENTER'.

39. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
    Figure 5, page 7.

40. At the Enter your Selected Operation prompt, type a 6 (Return to
    Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
    Selection Menu appears. See Figure 4, page 7.

41. As you complete data entry for each segment, put your initials and
    the date in the appropriate spaces provided on the PEX Checklist.

## Enter Selected Clinical Observations

Follow these steps to enter selected clinical observations information
manually. To save time, you can copy Clinical Observations from a
previous study (see "Copy PEX Segments").

42. At the Enter your selection: prompt on the PEX EIS Segment Selection
    Menu, type a 3 (Selected Clinical Observations). Press \<ENTER\>.
    The Segment OPERATION Selection Menu appears.

43. At the Enter your Selected Operation prompt, type a 1 (ADD Segment).
    Press \<ENTER\>. The following message appears:

44. The Selected Clinical Observations screen appears:

45. ![](media/image9.emf){width="5.495833333333334in"
    height="3.0756944444444443in"}

Figure 8, Selected Clinical Observations

46. At the Enter Your Selected Operation: prompt on the Selected
    Clinical Observations screen, type 2 (Modify Segment). Press
    \<ENTER\>. The Clinical Observations screen appears.

47. ![](media/image10.emf){width="5.498611111111111in"
    height="2.9305555555555554in"}

Figure 9, Clinical Observations

48. At the Enter Your Selection: prompt on the Clinical Observations
    screen, type 1 (Selected Clinical Observations). Press \<ENTER\>.

49. 

50. The Selected Clinical Observations screen appears:

51. ![](media/image11.emf){width="5.498611111111111in"
    height="2.8965277777777776in"}

Figure 10, Selected Clinical Observations (MOD)

52. Enter the codes that appear in the General, Behavior, and Lesions
    Clinical Observation tables (see Appendix C). If you are entering
    data for a skin application study, you must also include the codes
    listed in the Site of Application table.

NOTE

> The Site and Size fields on this screen are no longer applicable,
> unless Required, 'R', is on the Clinical Observation Tables in
> Appendix C.

53. After you enter all of the codes, press G-4 to save the segment. The
    following message appears:

54. This segment has been written to the database. Hit 'ENTER'.

55. Press \<ENTER\>.

56. The Selected Sites screen appears:

57. ![](media/image12.emf){width="5.498611111111111in"
    height="3.06875in"}

Figure 11, Selected Sites (MOD)

58. Enter the codes as they appear in the Selected Sites table (see
    Appendix C).

59. Press G-4 to save the segment. The following message appears:

60. This segment has been written to the database. Hit 'ENTER'.

61. Press \<ENTER\>. The Selected Sizes screen appears.

![](media/image13.emf){width="5.497222222222222in"
height="3.0722222222222224in"}

Figure 12, Selected Sizes (MOD)

62. Enter the codes exactly as they appear in the Selected Sizes table
    (see Appendix C).

63. Press G-4 to save the segment. The following message appears at the
    top of the screen:

64. This segment has been written to the database. Hit 'ENTER'.

65. Press \<ENTER\>.

66. The Reasons for Removal screen appears:

67. ![](media/image14.emf){width="5.495833333333334in"
    height="3.1951388888888888in"}

Figure 13, Reasons for Removal (MOD)

68. Enter the codes exactly as they appear in the Removal Reasons table
    (see Appendix C).

69. Press G-3 to save the segment. The following message appears:

70. This segment has been written to the database. Hit 'ENTER'.

71. Press \<ENTER\>. The Clinical Observations screen appears. See
    Figure 9, page 12.

72. At the Enter Your Selected Operation: prompt on the Clinical
    Observations screen, type a 6. Press \<ENTER\>. The Segment
    Operation Selection Menu appears. See Figure 5, page 7.

73. At the Enter Your Selected Operation: prompt on the Segment
    Operation Selection Menu, type at 5. Press \<ENTER\>. The PEX EIS
    Segment Selection Menu appears.

## Enter Animal Removal Actions

Follow these steps to enter animal removal actions information:

74. At the Enter your Selection: prompt on the PEX EIS Segment Selection
    Menu, type a 5 (Animal Removal Actions).

75. At the Enter your Selected Operation: prompt, type a 1 (ADD
    Segment). The Removal Actions screen appears:

76. ![](media/image15.emf){width="5.497916666666667in"
    height="2.8993055555555554in"}

Figure 14, Removal Actions (ADD)

77. Enter the removal data exactly as it appears on the manual form.
    Press G-3 to save the segment. The following message appears at the
    top of the screen:

78. This segment has been written to the database. Hit 'ENTER'.

79. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
    Figure 5, page 7.

80. At the Enter your Selected Operation prompt, type a 5 to select the
    option, Return to Segment Selection Menu. Press \<ENTER\>. The PEX
    EIS Segment Selection Menu appears. See Figure 4, page 7.

81. As you complete data entry for each segment, put your initials and
    the date in the appropriate spaces provided on the PEX Checklist.

## Enter Rack-Cage Configuration

Follow these steps to enter rack and cage configuration information:

82. At the Enter your selection: prompt on the PEX EIS Segment Selection
    Menu, type a 6 (Rack-Cage Configurations). Press \<ENTER\>. The
    Segment OPERATION Selection Menu appears. See Figure 5, page 7.

83. At the Enter Your Selected Operation: prompt, type 1 (ADD Segment).
    Press \<ENTER\>. The Rack-Cage screen appears.

84. ![](media/image16.emf){width="5.4944444444444445in"
    height="2.920138888888889in"}

Figure 15, Rack-Cage (ADD)

85. Enter the data exactly as it appears on the Rack-Cage Configuration
    manual form.

NOTE

> The data on each page of the manual forms corresponds to the Rack-Cage
> segments that appear on your screen individually. You must save each
> segment individually after data entry.

86. Press G-4 to save the segment and add the next segment. The
    following message appears:

87. This segment has been written to the database. Hit 'ENTER'.

88. Press \<ENTER\>. A blank Rack-Cage screen appears. Continue to enter
    data and save the individual segments until you have completed entry
    of all Rack-Cage data that appears on the manual forms.

89. After you enter the final segment, press G-3 to save the completed
    segment. The following message appears:

90. This segment has been written to the database. Hit 'ENTER'.

91. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
    Figure 5, page 7.

92. At the Enter Your Selected Operation: prompt, type a 6 (Return to
    Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
    Selection Menu appears. See Figure 4, page 7.

93. As you complete data entry for each segment, put your initials and
    the date in the appropriate spaces provided on the PEX Checklist.

## Enter Cage Census Definition

Follow these steps to enter the cage census definition information:

94. From the PEX EIS Segment Selection Menu, type a 7 (Cage Census
    Definitions) at the Enter your Selection: prompt. Press \<ENTER\>.
    The Segment OPERATION Selection Menu appears.

95. At the Enter Your Selected Operation: prompt, type a 1 (ADD
    Segment). Press \<ENTER\>. The Census Definition screen appears:

96. ![](media/image17.emf){width="5.49375in"
    height="2.9583333333333335in"}

Figure 16, Census Definition (ADD)

97. Enter the data exactly as it appears on the Census Definition
    Configuration manual form.

98. Press G-4 to save the segment and add the next segment. The
    following message appears:

99. This segment has been written to the database. Hit 'ENTER'.

100. Press \<ENTER\>. A blank Census Definition screen appears. Continue
     to enter data and save the individual segments until all cage
     census definition data entry is complete.

101. Press G-3 to save the completed segment. The following message
     appears:

102. This segment has been written to the database. Hit 'ENTER'.

103. Press \<ENTER\>. The Segment OPERATION Selection Menu appears.

104. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
     Selection Menu appears. See Figure 4, page 7.

105. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaces provided on the PEX Checklist.

## Enter Preparation Definition

Follow these steps to enter the preparation definition information:

106. From the PEX EIS Segment Selection Menu, type an 8 (Preparation
     Definition) at the Enter your Selection: prompt. Press \<ENTER\>.
     The Segment OPERATION Selection Menu appears. See Figure 5, page 7.

107. At the Enter your Selected Operation: prompt, type 1 (ADD Segment).
     Press \<ENTER\>. The Preparation Definition screen appears:

108. ![](media/image18.emf){width="5.49375in"
     height="2.951388888888889in"}

Figure 17, Preparation Definition (ADD)

109. Enter the data exactly as it appears on the Preparation Definition
     manual form.

NOTE

> The compound for Preparation ID \# may be a vehicle. Do not complete
> the last two fields on the screen.

110. Press G-4 to save the segment and add the next segment. The
     following message appears:

111. This segment has been written to the database. Hit 'ENTER'.

112. Press \<ENTER\>. A blank Preparation ID screen (Preparation ID #2
     appears.

113. If the preparation ID is a test compound, enter the data and press
     G-0 to add the substructure for the vehicle. A Preparation
     Definition screen appears with the same ID number (#2) in the first
     field. Enter the data for the remaining fields. Continue to add
     individual substructures until data entry for Preparation ID #2 is
     complete.

114. Press G-4 to save the completed segment. The following message
     appears:

115. This segment has been written to the database. Hit 'ENTER'.

116. The Preparation Definition screen appears. Repeat Steps 3-6 above
     to enter data associated with each additional Preparation
     Definition ID.

117. After data entry for all Preparation Definition IDs is complete,
     press G-3. The following message appears:

118. This segment has been written to the database. Hit 'ENTER'.

119. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

120. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaces provided on the PEX Checklist.

121. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
     Selection Menu appears. See Figure 4, page 7.

## Enter Procedure Definition

Follow these steps to enter the procedure definition information:

122. From the PEX EIS Segment Selection Menu, type 9 (Procedure
     Definition) at the Enter your Selection: prompt. Press \<ENTER\>.
     The Segment OPERATION Selection Menu appears. See Figure 5, page 7.

123. At the Enter Your Selected Operation: prompt, type 1 (ADD Segment).
     Press \<ENTER\>. The Procedure Definition screen appears:

124. ![](media/image19.emf){width="5.498611111111111in"
     height="2.9618055555555554in"}

Figure 18, Procedure Definition (ADD)

125. Enter the data exactly as it appears on the Procedure Definition
     manual form. Procedure definition segments are grouped by procedure
     ID numbers (item 1 on the manual form). Several substructures or
     actions (item 2 on the manual form) can be assigned to a single
     procedure ID number.

126. After you have entered the first action for a procedure ID number,
     press G-0. The cursor then returns to the action field so you can
     add another action for this procedure ID number.

127. After you have entered all the actions for the first procedure ID,
     press G-4 to save the segment. The following message appears:

128. This segment has been written to the database. Hit 'ENTER'.

129. Press \<ENTER\>. The cursor returns to the first field on the
     screen.

130. Enter the data for the next procedure ID beginning with Step 3
     above. Continue to enter the data and save the individual segments
     until you have completed entry of all Procedure Definition data.

131. When you have completed data entry, press G-3 to save the segment.
     The following message appears:

132. This segment has been written to the database. Hit 'ENTER'.

133. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

134. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
     Selection Menu appears. See Figure 4, page 7.

135. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaces provided on the PEX Checklist.

## Enter Treatment Definition

Follow these steps to enter the treatment definition information:

136. From the PEX EIS Segment Selection Menu, type a 10 (Treatment
     Definition) at the Enter your Selection: prompt. Press \<ENTER\>.
     The Segment OPERATION Selection Menu appears.

137. At the Enter your Selected Operation: prompt, type 1 to add a
     segment. Press \<ENTER\>. The Treatment Definition screen appears:

138. ![](media/image20.emf){width="5.495833333333334in"
     height="3.0076388888888888in"}

Figure 19, Treatment Definition (ADD)

139. Enter the data exactly as it appears on the Treatment Definition
     manual form.

NOTE

> The Text ID of group appears as two lines of eight characters each on
> the TMDS Reports. Do not divide a word between the two Text ID of
> group lines when you enter the data on the Treatment Definition
> screen. IN the Table Number of Growth Change Limits field, enter one
> of the following codes according to sex and species: 1=male rats,
> 2=female rats, 3=male mice, or 4=female mice.

140. Press G-4 to save the segment and add the next segment. The
     following message appears:

141. This segment has been written to the database. Hit 'ENTER'.

142. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

143. After you have entered all the treatment definitions, press G-3 to
     save the completed segment. The following message appears:

144. This segment has been written to the database. Hit 'ENTER'.

145. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

146. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
     Selection Menu appears. See Figure 4, page 7.

147. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaced provided on the PEX Checklist.

## Enter Facility/Chemical Linkage

Follow these steps to enter the facility/chemical linkage information:

148. From the PEX EIS Segment Selection Menu, type an 11
     (Facility/Chemical Linkage Definition) at the Enter Your Selection:
     prompt. Press \<ENTER\>. The Segment OPERATION Selection Menu
     appears. See Figure 5, page 7.

149. At the Enter Your Selected Operation: prompt, type 1 (ADD Segment).
     Press \<ENTER\>. The Facility/Chemical Linkage Information screen
     appears:

150. ![](media/image21.emf){width="5.49375in" height="2.90625in"}

Figure 20, Facility /Chemical Linkage Information (ADD)

151. Enter the data exactly as it appears on the Facility/Chemical
     Linkage Information manual form. You must press \<RETURN\> at the
     end of each line of data you type- text does not wrap
     automatically.

> NOTE 1: In the Protocol Required Tissue Flag field, enter an L if the
> study is subchronic or an M if the study is chronic. (L indicates data
> will be entered at the lab facility; M indicates data will be
> downloaded from the mainframe).
>
> NOTE 2: The Principal Investigator is a required entry on the
> Facility/Chemical Linkage Information screen, though it's not listed
> on the manual form. You must refer to the "Responsible Parties" form
> to obtain this information.
>
> NOTE 3: When entering data on the Facility/Chemical Linkage
> Information screen, you must include hyphens in the Contract number(s)
> for test field.

152. Facility/Chemical Linkage Information requires data entry on two
     different screens. After completing entry on the first screen,
     press G-0 to save the first portion of the data. The second
     Facility/Chemical Linkage Information screen appears.

153. ![](media/image22.emf){width="5.497916666666667in"
     height="3.011111111111111in"}

Figure 21, Facility/Chemical Linkage Information (cont..)

154. Complete Facility/Chemical Linkage Information data entry on this
     screen.

> The NTP Number of test compound field has only six spaces. Include the
> C at the beginning of the NTP number if there is no letter at the end
> of the NTP number. If there is a letter at the end of the number,
> leave off the beginning C.
>
> You must include hyphens in the CAS number of test compound field.

155. After you have entered all the Facility/Chemical Linkage
     Information data entry, press G-3 to save the segment. The
     following message appears:

156. This segment has been written to the database. Hit 'ENTER'.

157. Press \<ENTER\>. The PEX EIS Segment Selection Menu appears. See
     Figure 4, page 7.

158. At the Enter Your Selected Operation: prompt, type a 5 (Return to
     Segment Selection Menu).

159. Press \<ENTER\>. The PEX EIS Segment Selection Menu appears. See
     Figure 4, page 7.

160. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaces provided on the PEX Checklist.

## Enter Responsible Parties

Follow these steps to enter the Responsible Parties:

161. From the PEX EIS Segment Selection Menu, type a 12 (Responsible
     Parties) at the Enter Your Selection: prompt. Press \<ENTER\>. The
     Segment OPERATION Selection Menu appears. See Figure 5, page 7.

162. At the Enter Your Selected Operation: prompt, type 1 (ADD Segment).
     Press \<ENTER\>. The Responsible Parties screen appears:

163. ![](media/image23.emf){width="5.499305555555556in"
     height="3.011111111111111in"}

Figure 22, Responsible Parties (ADD)

164. Enter the data exactly as it appears on the Responsible Parties
     manual form. Press G-4 to save the segment. The following message
     appears:

165. This segment has been written to the database. Hit 'ENTER'.

166. Press \<ENTER\>. The cursor returns to the first field on the
     screen.

167. Repeat Step 3 until you have entered the Principal Investigator and
     the Project Officer (there is on Chemical Manager).

168. Press G-3 to save the completed segment. The following message
     appears:

169. This segment has been written to the database. Hit 'ENTER'.

170. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

171. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). Press \<ENTER\>. The PEX EIS Segment
     Selection Menu appears. See Figure 4, page 7.

172. As you complete data entry for each segment, put your initials and
     the date in the appropriate spaces provided on the PEX Checklist.

## Enter Balance Calibration Weights

Follow these steps to enter the balance calibration weights information:

173. From the PEX EIS Segment Selection Menu, type 13 (Balance
     Calibration Weights) at the Enter Your Selection: prompt. Press
     \<ENTER\>. The Segment OPERATION Selection Menu appears. See Figure
     5, page 7.

174. At the Enter Your Selected Operation: prompt, type 1 to add a
     segment. Press \<ENTER\>. The Balance Calibration Weights screen
     appears:

175. ![](media/image24.emf){width="5.389583333333333in"
     height="2.9791666666666665in"}

Figure 23, Balance Calibration Weights (ADD) screen

176. Enter the data exactly as it appears on the Balance Calibration
     Weights manual form.

177. Press G-3 to save the completed segment. The following message
     appears:

178. This segment has been written to the database. Hit 'ENTER'.

179. Press \<ENTER\>. The Segment OPERATION Selection Menu appears. See
     Figure 5, page 7.

180. At the Enter Your Selected Operation: prompt, type a 6 (Return to
     Segment Selection Menu). The PEX EIS Segment Selection Menu
     appears. See Figure 4, page 7.

## File the Forms

After you have completed data entry for all manual forms and proofread
the Validation Report, file the packet of forms and the checklist in the
experiment file.

# Copy PEX Segments from Previous Studies

If a study that is similar to the study you are entering into the
database already exists, you may choose to copy segments of the existing
study into the new study, then make minor modifications (according to
the manual forms) to the data wherever necessary.

The Clinical Observations segment can always be copied from a previous
study to save time. If the study you are entering is a skin application
study, make sure you copy the Clinical Observations segment from a study
that corresponds. Likewise, if the new study is not a skin application
study, make sure you copy the Clinical Observations segment from a
non-skin application study.

Follow these steps to copy PEX segments from the previous studies:

181. "Register new experiment" as described in the previous section.

182. From the PEX EIS Segment Selection Operation Menu, type a 3 (Copy
     EIS Segments from Existing Experiments) at the Enter Your
     Selection: prompt.

183. The study number field at the bottom of the screen displays the
     study you just registered.

184. Press \<ENTER\>.

185. The PEX EIS Copy Selection List screen appears:

186. ![](media/image25.emf){width="5.495833333333334in"
     height="2.9055555555555554in"}

Figure 24, PEX EIS Copy Selection List screen

187. In the Copy From Study Number field next to each segment (1-12),
     type the nine-digit study number for each segment you wish to copy.
     If no copy is to be made to a particular segment, leave that field
     blank.

188. Verify that all the study numbers are accurate.

189. Press \<ENTER\>. The following message appears:

190. Are you sure you want to copy ALL replicates for selected segments?
     (Y?N)

191. Type Y, then press \<ENTER\>. The following message appears.

192. Copying of selected segments has been completed. Hit \<ENTER\>.

193. Press \<ENTER\>.

194. If there are no problems copying data from one study to another,
     the PEX EIS Operation Selection Menu appears:

195. ![](media/image26.emf){width="5.4944444444444445in"
     height="3.192361111111111in"}

Figure 25, PEX EIS Operation Selection Menu

196. If there are problems copying data, an error message displays at
     the top of the PEX EIS Copy Selection List and the following
     message appears at the bottom of the screen:

197. ![](media/image27.emf){width="5.498611111111111in"
     height="2.9444444444444446in"}

Figure 26, PEX EIS Copy Selection List (Error)

198. You have three options: append to the existing data, delete the
     existing data by copying over it, or abort copying this segment but
     continue copying other segments. In most cases, you will want to
     abort, correct the data, and reissue the copy command. Make your
     selection by typing in the word APPEND, DELETE, or ABORT.

199. Press \<ENTER\>. PEX EIS Operation Selection Menu appears. See
     Figure 4, page 7.

# Modify PEX Segments

If any of the segments you copied require modification, or if a segment
requires correction due to data entry error, follow these procedures:

200. At the Please enter the NUMBER of your choice: prompt on the PEX
     EIS Operation Selection Menu screen, type a 2 (Modify Experiment).

201. At the Please enter the nine-digit study number: prompt, type in
     the study number. Press \<ENTER\>. The PEX EIS Segment Selection
     Menu appears:

202. ![](media/image28.emf){width="5.498611111111111in"
     height="3.077777777777778in"}

Figure 27, PEX EIS Segment Selection Menu

203. At the Enter your selection: prompt, type the number of the segment
     you wish to modify. Press \<ENTER\>. The series of screens
     appropriate to you selection will appear. Modify the data as
     necessary.

204. After you have completed data modification according to the manual
     forms and proofread the Validation Report, make sure you have
     checked off all modified segments on the PEX Checklist. File the
     packet of forms and the checklist in the experiment file.

PAS Validation Report Procedures

The following sections describe the procedures to generate, review, and
transmit the PAS Validation Report.

After adding a study to the PAS database, the liaison generates and
prints the PAS Validation Report to verify that the data has been
entered correctly.

After generating and printing data, the originating liaison reviews any
error messages on the Error Report, which is part of the Validation
Report. The liaison then corrects any errors using PEX and reruns the
Validation Report. The liaison repeats this process until the protocol
data is accurate.

A liaison other than the individual who initially entered the data
compares the Validation Report with the manual forms to verify data
entry.

# Generate the PAS Validation Report

Follow these steps to generate the PAS Validation Report:

205. At the prompt, type \@TDMS. Press \<ENTER\>. The TDMS Main Menu
     appears. See Figure 1, page 5.

206. At the Please enter the NUMBER of your choice prompt, type 1
     (Protocol Analysis System). Press \<ENTER\>. The PAS Main Menu
     appears: See Figure 2, page 5.

207. At the Enter Selection Code prompt, type EV (EIS Validation Report
     Request). Press \<ENTER\>. The PAS Validation Report Request-EIS
     screen appears:

208. ![](media/image29.emf){width="5.499305555555556in"
     height="2.923611111111111in"}

Figure 28, PAS Validation Report Request- EIS screen

209. Request number 15 (All Reports less schedules) or an alternate
     report. Follow the appropriate procedure described below.

## Total Validation Set, Less Schedules

Follow these steps to generate all the validation reports but no
schedules:

210. At the Please enter the NUMBER of your choice: prompt on the PAS
     Validation Report Request-EIS screen, type a 15 for Total
     Validation Set (All Reports less schedules).

211. In the Agency/Experiment/Test field, type the study number.

212. If you wish to print the report at TPMC, follow these steps:

213. Type a Y in the Print (Y/N)? field.

214. The Destination field may be completed in one of the following two
     ways:

-   To send the report to the Starprint Directory, type NOPRINT in the
    Destination field, then press \<ENTER\>. The NOPRINT command allows
    you to store the file in the temporary Starprint Directory so that
    you can print immediately or later (the Starprint Directory is
    purged every few days).

-   To print the report at TPMC immediately without retaining a copy of
    the report in the Starprint Directory, type the name of a printer
    located in the Destination field, then press \<ENTER\>.

215. If the Validation Report you are preparing is a final version,
     store the report on STARPRINT by typing a Y in the Store (Y/N)?
     field. Later, you may transmit this report to the lave without
     regenerating it.

216. In the Destination field, type NOPRINT. Press \<ENTER\>.

217. Press G-2. The PAS Main Menu appears.

218. Press G-5 to exit TDMS.

219. At the prompt, type show queue starbatchq (or your assigned logical
     for this command) to display all of the Star Queues. The Star
     Queues display indicates whether the file is waiting in the queue
     or executing. When the job completes, a message appears indicating
     the validation report has been generated. A sample message follows:

Job SPAEISTOTAL1_0509999902 (queue HAZEL_STAR, entry 369) completed

220. At the prompt, type the following character string: DIR/SIN
     STARPRINT: Name of Report (for example, DIR/SIN STARPRINT:
     SPAEISTOTAL1\*) Press \<ENTER\>. Three separate reports are
     prepared for printing; however, you will only print the error and
     validation reports. The report names are listed on the screen. An
     example follows:

  ------------------------------------- --------------------------------------
  SPAEISTOTAL1_0509999902_ERROR.LIS;1   SPAEISTOTAL1_0509999902_REPORT.LIS;1

  SPAEISTOTAL1_0509999902_RLVL2.LIS;1   
  ------------------------------------- --------------------------------------

221. 

222. Follow these steps to print the validation and error reports to the
     TDMSPRINT destination:

For the example displayed above, you would type the following character
string at the prompt to print the validation report:

PRINT/QUEUE=TDMSPRINT STARPRINT:SPAEISTOTAL1_0509999902_REPORT.LIS;1

## Individual Reports

Follow these steps to generate one or more individual reports:

223. At the Please enter the NUMBER of your choice: prompt on the PAS
     Validation Report Request-EIS screen, type the number of the report
     you wish to generate (1-14).

When you request a Procedure Action Schedule (13) you will have to enter
a start date.

224. In the Agency/Experiment/Test field, type the study number.

225. Follow Step 3 of "Total Validation Set, Less Schedules" to print or
     store the report on Starprint Directory. Press \<ENTER\>.

# Verify the PAS Validation Report

Follow these steps to verify the PAS Validation Report:

226. When you obtain the PAS Validation Report, determine if the errors
     flagged on the report are due to data entry error or invalid data.

Even if no errors were found during the validation process, the Error
Report displays the following message:

227. \*\*\*\*SEVERE ERROR\*\*\*\* NO ACTIVE ANIMAL ID DATA FOUND

NOTE

> This error was used for a segment that LDAS no longer uses; disregard
> the message when it appears in this report.

228. If you get any messages other than the error shown above, check the
     Validation Report for missing data, incomplete fields, conflicting
     data, invalid codes, and erroneous values. Check each page, field
     by field, against the appropriate manual form.

229. If you find data entry errors, correct the errors using the
     procedures described in the "PEX Manual Data Entry" section (access
     the screens in the MODIFY mode). Then rerun the corrected
     portion(s) of the report using the procedures described in the
     "Generate the PAS Validation Report" section.

230. If additional errors are found, repeat Step 3. If no additional
     errors are found, give the report to another liaison who will
     perform a second verification.

231. If you find an error not related to data entry, determine the
     severity of the error. A minor error consists of missing or
     incorrect information. A missing form would be a major error. Take
     one of the following steps based on your determination:

-   If the error is minor, call the lab's data administrator to confirm
    the error and get directions to correct it. On the form, note the
    correction, your initials, and the date. Ask the data administrator
    to submit a new manual form to reflect the correction.

-   If the error is major, call the data administrator and request a
    corrected form.

232. Regenerate the Validation Report using the procedures described in
     "Generate the PAS Validation Report."

# Certify PAS Data

Follow these steps to certify PAS data:

233. Follow these steps to certify PAS data:

234. Rename the report you wish to transmit by typing the following
     command at the prompt (XXXXXXX=study name; username=your name):

REN STARPRINT:SPAEISTOTAL1=05XXXXXXX_REPORT.LIS;1
XXXXXXX_username_000.EDR

235. Press \<ENTER\>.

236. To transmit the report to the lab, type the following command at
     the prompt (XXXXXXX=study name; YYY=the lab facility code):

\@SUTPRINT YYY STARPRINT:XXXXXXX_username_000.EDR

237. Press \<ENTER\>.

238. Before calling the lab facility to let the data administrator know
     you have transmitted the report, type the following command string
     at the prompt to make sure all the files transmitted successfully
     (YYY=the lab facility code):

DIR YYYREPORTS

239. Press \<ENTER\>.

A list of files currently in the Lab Reports Directory appears on the
screen.

240. The data administrator will contact you immediately to approve the
     report or to inform you of changes to make. Follow these steps:

241. If the problem is minor, note the correction, your initials, and
     the date on the original manual form. Ask the data administrator to
     submit a new manual form reflecting the correction.

If the problem is major, ask the data administrator to submit new
paperwork, as appropriate.

NOTE

> Corrected forms submitted by the data administrator must carry an
> authorized signature and the date of the correction. In addition, some
> labs may stamp the forms with a CORRECTION stamp.

242. Use PEX to enter the correction(s). (See the *Enter PEX Data*
     section in Chapter 2).

243. Rerun the modified parts of the PAS Validation Report.

244. Generate the PAS Validation Report and send the corrected report to
     the data administrator.

245. File the corrected form with the original manual forms in the
     experiment file.

246. The data administrator re-examines the PAS Validation Report. When
     the data administrator is satisfied that the PAS Validation Report
     accurately reflects the experiment's protocol, you will be notified
     to download the file.

247. The data administrator returns the TDMS PAS EIS/PEIS Data
     Certification form (the first page of the PAS Validation Report)
     with the approval signature of the reviewer at the laboratory to
     the liaison.

248. Store the verified PAS Validation Report in the laboratory files.
     Initialize and date the PEX Checklist.

In-Life Download Procedures

This chapter addresses the in-life download system.

The liaison uses the PAS Download system to transfer TDMS protocol data
from the mainframe to a lab's on-site microcomputer.

# Create In-Life Download Files

To create the in-life download files, follow these steps:

249. Type \@TMDS at the prompt. Press \<ENTER\>. The TDMS Main Menu
     appears. See Figure 1, page 5.

250. At the Please enter the NUMBER of your choice prompt, type a 1
     (Protocol Analysis System). Press \<ENTER\>. The PAS Main Menu
     appears. See Figure 2, page 5.

251. At the PAS Main Menu, select Create Download File by typing in the
     selection code CD at the Enter Selection Code prompt. Press
     \<ENTER\>. The Select Transaction Type screen appears:

252. ![](media/image30.emf){width="5.495833333333334in"
     height="3.075in"}

Figure 29, Select Transaction Type screen

253. Complete the fields of the Select Transaction Type screen by
     following these steps. When you enter information in the field, the
     cursor automatically moves to the next field.

254. In the Experiment/Test field, type in the number of the study you
     wish to download.

255. In the Destination Site field, type in the three-letter lab
     facility code.

256. In the Download All EIS Transaction field, type an X in the space
     provided. Press \<ENTER\>. The following message appears.

257. Download job submitted for all EIS transaction types. Press
     \<ENTER\> to continue.

258. Press G-5 to exit TDMS. A message appears indicating the download
     job is complete.

259. To verify the download was successful, follow these steps:

260. At the prompt type: DIR YYYDOWNLOAD (where YYY = the lab facility
     code).

Press \<RETURN\>. Make sure the file you download appears. For example,
EXXXXXXX.DNL;1

261. Notification of any errors that occurred during the download are
     sent via e-mail.

262. To delete a download file that contains errors from the Lab
     Download directory, at the prompt, type in the file to be deleted
     using the following format: DEL FILENAME.DNL;VERSION

For example: DEL YYYDownload:EXXXXXXX.DNL;Version

Repeat Steps 3 through 6 to create a new download.

# Modify PAS Data After In-Life Download

When corrections to an experiment's PAS Database must be made after the
files have been downloaded to the site, follow these steps:

263. Follow the steps in the "Enter Data Manually" section to modify the
     appropriate PEX segment(s).

264. Follow the steps in the "Generate the PAS Validation Report"
     section to rerun the affected segment(s) of the Validation Report.

265. Verify the Validation Report and file a copy in the experiment
     file.

266. Follow the steps in the "Certify the PAS Data" section to
     re-transmit the modified segment(s) of the PAS Validation Report to
     the data administrator.

267. After the data is verified by the data administrator, determine
     which download files to re-transmit.

268. Download the modified files using the steps described in the
     section "Create In-Life Download Files." However, do not download
     the full PAS file again. Perform a partial download as described
     below.

# Perform a Partial Download of Modified Transactions

Follow these steps to download only those transactions that were
modified:

269. At the PAS Main Menu, select Create Download File by typing in the
     selection code CD at the Enter Selection Code prompt. Press
     \<ENTER\>. The Select Transaction Type screen appears. See Figure

270. 

271. Complete the fields of the Select Transaction Type screen by
     following these steps. When you enter information in the field, the
     cursor automatically moves to the next field.

272. In the Experiment/Test field, type in the number of the study you
     wish to download.

273. In the Destination Site field, type in the three-letter lab
     facility code.

274. In the Select EIS Transactions field, type an X in the space
     provided. Press \<ENTER\>.

The Select EIS Transactions to Download screen appears:

![](media/image31.emf){width="5.495138888888889in"
height="3.0972222222222223in"}

Figure 30, Select EIS Transactions To Download

275. Select the transactions that were corrected by typing an X next to
     the affected transactions. Press \<ENTER\>.

NOTE

> Refer to Chapter 3 in the *LDAS Technical Reference Manual* to
> determine which EIS transactions to download.

Select Weight Group if the Data Administrator changes the weight limits
for bottles or feeders.

Select **Treatment** if the laboratory changes the consumption values.

If the **Test** transaction is downloaded and initialized, the start
date and set number on the laboratory Communications Workstation will be
destroyed. The Data Administrator will have to reload the animals to
reestablish the start date and use the maintenance utility Modify
Transaction Set Number.

**In-Life Terms** may be downloaded if there is a term added for the
study.

TDMS Code Tables are only selected when there is a modification to the
TDMS table while the study is in progress.

The following table shows the correlation between PEX segment or TDMS
code table and EIS transaction.

+---------------------------+------------------------------------------+
| **EIS Transaction**       | **PEX Segment or TDMS Code Table**       |
+---------------------------+------------------------------------------+
| Cage                      | Rack-cage Configuration                  |
+---------------------------+------------------------------------------+
| Weight Status             | Weight Status Table                      |
|                           |                                          |
|                           | Cage and Animal status codes             |
+---------------------------+------------------------------------------+
| Clinical Signs            | Clinical Observations                    |
|                           |                                          |
| Qualifier Groups/Clinical |                                          |
| Signs Sites/Clinical      |                                          |
| Signs                     |                                          |
+---------------------------+------------------------------------------+
| In-Life Qualifiers        | Sizes substructure of clinical           |
|                           | observations segment                     |
+---------------------------+------------------------------------------+
| In-Life Qualifier Groups  | In-Life Qualifier Group Names            |
+---------------------------+------------------------------------------+
| In-Life Sites             | Sites substructure of clinical           |
|                           | observations segment                     |
+---------------------------+------------------------------------------+
| Preparation               | Preparation Definition                   |
|                           |                                          |
| Preparation/Treatment     |                                          |
| Groups                    |                                          |
+---------------------------+------------------------------------------+
| Procedure                 | Cage Group Procedure Definition          |
+---------------------------+------------------------------------------+
| Removal Actions           | Animal Removal Actions                   |
+---------------------------+------------------------------------------+
| Test                      | Facility/Chemical Linkage Information    |
+---------------------------+------------------------------------------+
| Weight Group              | Weighed Items Range Validation           |
+---------------------------+------------------------------------------+
| In-Life Terms             | In-Life Terms Table                      |
|                           |                                          |
|                           | Definitions of Clinical Observations     |
+---------------------------+------------------------------------------+
| Calibration Weight        | Balance Calibration Weights              |
+---------------------------+------------------------------------------+
| Removal Reason            | Removal Reason substructure of Clinical  |
|                           | Observations                             |
+---------------------------+------------------------------------------+
| Treatment Preparation/    | Treatment Definition                     |
|                           |                                          |
| Treatment Groups          |                                          |
+---------------------------+------------------------------------------+
| Correction Reason         | Error Correction Reason Table            |
+---------------------------+------------------------------------------+

276. Press G-5 to exit TDMS. A message appears indicating the download
     job is complete. Refer to Step 6 in "Create In-Life Download Files"
     at the beginning of this chapter to verify the partial download was
     successful.

TDMS Tables

Use the TDMS Tables contained in this appendix as reference for TDMS
codes when entering and verifying PAS data.

## Facility Table

  ----------- --------------------- --------------------- ----------------
  **Code**    **Long-Text**         **Short-Text**        **City-State**

  4           Battelle Northwest    Battelle Northwest    Richland, WA

  5           American Biogenics    American Biogenics    Woburn, MA
              Corp.                                       

  6           SRI, International    SRI, Int'l            Menlo Park, CA

  7           Midwest Research      Midwest Research Inst Kansas City, MI
              Institute                                   

  8           Hazleton, Maryland    Hazleton, MD          Rockville, MD

  9           Southern Research     Southern Research     Birmingham, AL
              Institute             Inst                  

  14          BioReliance           Microbiological       Rockville, MD
                                    Assoc.                

  16          Battelle Columbus     Battelle Columbus     Columbus, OH
              Laboratory                                  

  18          National Cancer       National Cancer Inst  Bethesda, MD
              Institute                                   

  19          National Center for   NCTR                  Jefferson, AK
              Toxicological                               
              Research                                    

  20          National Institute    NIEHS                 RTP, NC
              for Environmental                           
              Health Sciences                             

  23          TSI Mason Research    Mason                 Worcester, MA
  ----------- --------------------- --------------------- ----------------

  ----------- --------------------- --------------------- ----------------
  27          International         IRDC                  Mattawan, MI
              Research and                                
              Development Corp.                           

  29          Experimental          EPL                   RTP, NC
              Pathology                                   
              Laboratories                                

  31          Hazleton Laboratories HLA, VA               Vienna, VA
              America, Inc.                               

  34          Lovelace Inhalation   LITRI                 Albuquerque, NM
              Toxicology Research                         
              Institute                                   

  35          Brookhaven National   Brookhaven            Upton, NY
              Laboratory                                  

  36          Northrup Services,    Northrup Services     RTP, NC
              Inc.                                        

  37          Pathco                Pathco                RTP, NC

  39          I.I.T. Research       IITRI                 Chicago, IL
              Institute                                   

  40          Arthur D. Little Life A.D. Little           Cambridge, MA
              Science Laboratories                        

  41          Pathology Associates, PAI                   Frederick, MD
              Inc.                                        
  ----------- --------------------- --------------------- ----------------

## Action Table

  ------------------ ----------------------------------------------------
  **Code**           **Long-Text**

  4                  Weigh Old Feeder

  5                  Weigh New Feeder

  6                  Weigh Old Bottle

  7                  Weigh New Bottle

  12                 Remove One Animal

  13                 Remove All Animals in One Cage

  100                Weigh Animal

  101                Enter Clinical Observations

  107                Enter Carcass Identification

  108                Enter Reason for Removal
  ------------------ ----------------------------------------------------

## Weight Table

  -------------- -------------------------------- ------------------------
  **Code**       **Long-Text**                    **Short-Text**

  7              Old Water Bottle                 O Bottle

  8              New Water Bottle                 N Bottle

  9              Old Feeder                       O Feeder

  10             New Feeder                       N Feeder
  -------------- -------------------------------- ------------------------

## Test Type Table

  ----------- ----------------------------- -----------------------------
  **Code**    **Long-Text**                 **Short-Text**

  4           Acute                         Acute

  5           14-Day Repeated Dose          14-Day Repeated

  6           Subchronic (90-day)           Subchron 90-Day

  7           Chronic                       Chronic

  8           Bioavailability Study         Bioavailability

  9           Special Study                 Special Study

  10          Initiation/Promotion Study    Init/Promot

  11          Subchronic (26-week)          Subchron 26-Week

  12          Mating Trial                  Mating Trial

  13          Six-Month Exposure            Six-Month Expos.

  14          Diet Restriction              Diet_Res

  15          Perinatal Exposure            Perinatal Expos

  16          90-Day w/ Perinatal Exposure  90-Day w/PN Exp

  17          Chronic 30-Month              Chronic 30-Month

  18          28-Day                        28-Day

  19          Subchronic (45-Day)           Subchron (45-Day)

  20          Subchronic (8-Week)           Subchron (8-week)
  ----------- ----------------------------- -----------------------------

## Dose Route Table

  ---------------- ------------------------------------------------------
  **Code**         **Long-Text**

  4                Dosed Feed

  5                Dosed Water

  7                Gavage

  8                Subcutaneous

  12               Intraperitoneal Injection

  15               Respiratory Exposure Whole Body

  16               Respiratory Exposure Nasal

  42               Skin Application

  43               Vaginal

  44               Initiation Promotion

  45               Magnetic Fields
  ---------------- ------------------------------------------------------

## Animal Supplier Table

  ---------------- ------------------------------------------------------
  **Code**         **Long-Text**

                   Not Specified

  1                Simonsen Labs

  2                Taconic Farms

  3                Frederick Cancer Research Facility

  4                Charles River

  5                Harlan Sprague-Dawley
  ---------------- ------------------------------------------------------

## Strain Table

  ---------- ------------------------- ----------------------- -----------
  **Code**   **Long-Text**             **Short-Text**          **Species
                                                               Code**

  4          Mice                      Mice                    4

  5          B6C3F1 Mice               B6C3F1                  4

  6          C57BL/6 Mice              C57BL/6                 4

  7          C3H Mice                  C3H                     4

  18         C3B6F1 Mice               C3B6F1                  4

  19         B6D2F1 Mice               B6D2F1                  4

  20         DBA/2 Mice                DBA/2                   4

  24         SENCAR Mice               SENCAR                  4

  31         CD-1 CRL Mice Outbred     CD-1 CRL                4
             Charles Rivers                                    

  34         Swiss Mice                Swiss                   4

  35         Swiss Webster Mice        Swiss Webst.            4

  87         MMTV/MYC Transgenic Mice  TG.M                    4

  88         MMTV/RAS Transgenic Mice  TG.SH                   4

  89         MMTV/NEU Transgenic Mice  TG.NK                   4

  90         PIM Transgenic Mice       PIM/TG                  4

  91         P53 Heterozygous          P53/TG                  4
             Transgenic Mice                                   

  92         TG.AC Hemizygous          TG.AC HEMI              4
             Transgenic mice                                   

  93         TG.AC Homozygous          TG.AC HOMO              4
             Transgenic mice                                   

  95         FVB/N mice                FVB/N                   4

  96         C57BL/6 - APC+/SPV -      TG:APC                  4
             1638N (TG:APC)                                    

  10000      Rats                      Rats                    10000

  10001      Fischer 344 Rats          Fischer 344             10000

  10002      Sprague-Dawley Rats       SD                      10000

  10007      Wistar Outbred Rats       Wistar Outbr            10000

  10009      Wistar Rats               Wistar                  10000

  10010      Osborne Mendel Rats       Osborne-Mend            10000

  20000      Hamsters                  Hamsters                20000

  20002      Syrian Hamsters           Syrian                  20000
  ---------- ------------------------- ----------------------- -----------

## Growth Weight Table

  ---------------------- ------------------------ ------------------------
  **Start-Week**         **Min-Weight**           **Max-Weight**

  100002                 -5                       61

  100003                 -5                       41

  100004                 -5                       28

  100005                 -5                       21

  100006                 -5                       17

  100007                 -5                       14

  100008                 -4                       14

  100009                 -4                       13

  100010                 -4                       12

  100011                 -4                       11

  100012                 -4                       10

  100013                 -4                       9

  100015                 -3                       7

  100016                 -2                       5

  100017                 -1                       3

  100019                 -2                       3

  100056                 -2                       2

  100071                 -3                       2

  100090                 -4                       2

  100092                 -5                       2

  100093                 -5                       2

  100099                 -6                       2

  100103                 -7                       2

  200002                 -5                       37

  200003                 -5                       29

  200004                 -5                       21

  200005                 -5                       17

  200006                 -5                       15

  200007                 -5                       13

  200008                 -5                       12

  200009                 -5                       11

  200010                 -5                       10

  200012                 -5                       9

  200014                 -5                       8

  200015                 -4                       7

  200016                 -3                       5

  200017                 -2                       4

  200036                 -2                       3

  200083                 -3                       3

  200103                 -4                       3

  300002                 -11                      26

  300003                 -12                      24

  300005                 -12                      23

  300008                 -12                      22

  300009                 -13                      21

  300010                 -13                      19

  300011                 -13                      18

  300013                 -13                      17

  300014                 -14                      16

  300015                 -11                      12

  300016                 -7                       9

  300017                 -3                       5

  300056                 -4                       4

  300071                 -5                       4

  300099                 -6                       4

  300103                 -6                       3

  400002                 -15                      25

  400003                 -15                      24

  400005                 -15                      23

  400007                 -15                      22

  400009                 -15                      21

  400012                 -14                      20

  400015                 -11                      16

  400016                 -7                       11

  400017                 -4                       7

  400044                 -4                       6

  400055                 -5                       6

  400084                 -5                       5

  400091                 -6                       5
  ---------------------- ------------------------ ------------------------

PEX Checklist

The PEX Checklist, which appears on the following page, is used to track
the completion of liaison procedures relative to the study.

Make a copy of this checklist whenever you are assigned a new study and
use it to track your progress.

**PEX Checklist**

Chemical Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Study Number:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Facility:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Species:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Route:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Study Type:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Start Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**PAS DATA ENTRY**

  ------------- -- ------ -------------------------------------------------
  Date                    Segment

                          

                   1\.    Weighed Items Range Validation

                   2\.    Loading Requirements and Weight Validation

                   3\.    Selected Clinical Observations

                   4\.    Animal Removal Actions

                   5\.    Balance Calibration Weights

                   6\.    Rack-Cage Configuration

                   7\.    Census Definition

                   8\.    Preparation Definition

                   9\.    Procedure Definition

                   10\.   Treatment Definition

                   11\.   Facility/Chemical Linkage Information

                   12\.   Responsible Parties
  ------------- -- ------ -------------------------------------------------

**VALIDATION REPORT**

  ------------- -- ------------------------------------------------------
                   Validation Report Printed

                   Validation Report Sent to Laboratory

                   Schedules sent to Laboratory

                   Certification Report received from Laboratory
  ------------- -- ------------------------------------------------------

**IN-LIFE DOWNLOAD**

  ------------- -- ------------------------------------------------------
                   EIS Download to Laboratory

  ------------- -- ------------------------------------------------------

**PATHOLOGY PEX**

  ------------- -- ------------------------------------------------------
                   Pathology Tables copied to the study

                   Pathology Required Tissues copied to chronic study

                   Pathology Validation Report Printed
  ------------- -- ------------------------------------------------------

**PATHOLOGY DOWNLOAD**

  ------------- -- ------------------------------------------------------
                   Pathology Download to Laboratory

  ------------- -- ------------------------------------------------------

TDMS Standard Clinical Observations

Use the tables contained in this appendix to manually enter selected
clinical observations.

## General

  ----------------- -----------------------------------------------------
  **Code**          **Term**

  62                Unremarkable

  37                Diarrhea

  64                Nasl/Eye Dschg

  102               Ruffled Fur

  2                 Thin

  185               Eye Abnormality
  ----------------- -----------------------------------------------------

## Behavior

  ----------------- -----------------------------------------------------
  **Code**          **Term**

  49                Ataxia

  12                Abnl Breathing

  186               Head Tilt

  65                Hyperactive

  60                Lethargic

  187               Paralysis

  6                 Tremors
  ----------------- -----------------------------------------------------

  ----------------- -----------------------------------------------------
  193               Hyperactivity

  194               Excitablity

  189               Clonic Seizures

  190               Tonic Seizures

  191               Impaired Gait

  192               Hindlimb Splay
  ----------------- -----------------------------------------------------

## Lesions

  ----------------- ------------------------- -------------- --------------
  **Code**          **Term**                                 

  20                Mass                      R              R

  22                Ulcer/Abcess              R              

  195               Papilloma                 R              R
  ----------------- ------------------------- -------------- --------------

## Site of Application

  -------------------------- --------------------------------------------
  **Code**                   **Term**

  134                        Carcinoma

  133                        Papilloma

  61                         Keratoacanthom

  131                        Irritation

  129                        Thickened

  123                        Ulcer
  -------------------------- --------------------------------------------

## Selected Sites

  -------------------------- --------------------------------------------
  **Code**                   **Term**

  10023                      Head

  10059                      Appendage

  10060                      Torso/Dorsal

  10061                      Torso/Lateral

  10062                      Torso/Ventral
  -------------------------- --------------------------------------------

## 

## Selected Sizes

  -------------------------- --------------------------------------------
  **Code**                   **Term**

  20070                      Small

  20071                      Medium

  20072                      Large
  -------------------------- --------------------------------------------

## Removal Reasons

  -------------------------- --------------------------------------------
  **Code**                   **Term**

  25017                      SSAC

  25018                      DACC

  25019                      MSAC

  25020                      NATD

  25021                      TSAC

  25022                      ACCK

  25023                      Miss

  25026                      Other
  -------------------------- --------------------------------------------

**End of Document**