**[Guidelines for Completing the ITPR Excel Workbook]{.underline}**

**Overview**

After the ITPR data is submitted to DCP, it goes through several data
quality checks. The following guidelines must be adhered to when
completing the ITPR Excel worksheets in order to avoid data
discrepancies that will prohibit the data from being loaded into the
database. The list below represents the guidelines for each worksheet
that is to be completed within the Excel workbook.

**Change Control**

  ------------- --------------- --------------------------------------------
  **Version**   **Guideline     **Description of Change**
                Number          
                Changed**       

  3             9               Added item "c" regarding the avoidance of
                                leading and trailing spaces in the
                                Registration and Randomization numbers.
  ------------- --------------- --------------------------------------------

Guidelines

+--------+---------+---------------------------------------------------+
| **Gui  | **Work  | **Guideline Instruction**                         |
| deline | sheet** |                                                   |
| Nu     |         |                                                   |
| mber** |         |                                                   |
+========+=========+===================================================+
| **1**  | On all  | NCI Protocol Number must be valid. It cannot be   |
|        | wor     | blank for any row that contains data and it must  |
|        | ksheets | exactly match the value in DCP\'s database.       |
|        |         | Please copy the value Westat provides in the      |
|        |         | first row to all subsequent rows on the template. |
|        |         | (TLC #1)                                          |
+--------+---------+---------------------------------------------------+
| **2**  | On all  | Reporting Period Start Date must be a valid       |
|        | wor     | reporting period as stated in the contract. It    |
|        | ksheets | cannot be blank for any row that contains data    |
|        |         | and it must exactly match the value in DCP\'s     |
|        |         | database. Please copy the value Westat provides   |
|        |         | in the first row to all subsequent rows on the    |
|        |         | template. (TLC #2.1)                              |
+--------+---------+---------------------------------------------------+
| **3**  | On all  | Reporting Period Start Date cannot have already   |
|        | wor     | been submitted and processed. (i.e. each quarter  |
|        | ksheets | has unique period dates) (TLC #2.2)               |
+--------+---------+---------------------------------------------------+
| **4**  | On all  | Reporting Period End Date must be a valid         |
|        | wor     | reporting period as stated in the contract. It    |
|        | ksheets | cannot be blank for any row that contains data    |
|        |         | and it must exactly match the value in DCP\'s     |
|        |         | database. Please copy the value Westat provides   |
|        |         | in the first row to all subsequent rows on the    |
|        |         | template. (i.e. each quarter has unique period    |
|        |         | dates) (TLC #3.1)                                 |
+--------+---------+---------------------------------------------------+
| **5**  | On all  | Reporting Period End Date cannot have already     |
|        | wor     | been submitted and processed (TLC #3.2)           |
|        | ksheets |                                                   |
+--------+---------+---------------------------------------------------+
| **6**  | P       | If a Comment Type is selected, a value must be    |
|        | rogress | present in the Comment field of that data row.    |
|        | C       | (TLC #4.1)                                        |
|        | omments |                                                   |
+--------+---------+---------------------------------------------------+
| **7**  | P       | Comment Type must be chosen from the drop-down    |
|        | rogress | list. The values available are: Accrual, Agent    |
|        | C       | Supply, Staffing, Other, and Correction (TLC      |
|        | omments | #4.2)                                             |
+--------+---------+---------------------------------------------------+
| **8**  | P       | If a value is present in the Comments field,      |
|        | rogress | there must be a Comment Type must be given for    |
|        | C       | that data row. (TLC #5)                           |
|        | omments |                                                   |
+--------+---------+---------------------------------------------------+
| **9**  | Cum     | a.  Registration Number and Randomization Number  |
|        | ulative |     must be less than 10 characters long, (TLC    |
|        | Part    |     #10)                                          |
|        | icipant |                                                   |
|        | Accrual | b.  Registration Number and Randomization Number  |
|        | and AEs |     must not consist of patient specific values   |
|        |         |     (i.e. Data of Birth, Initials, etc.) (TLC     |
|        |         |     #10)                                          |
|        |         |                                                   |
|        |         | c.  Registration Number and Randomization Number  |
|        |         |     should not contain leading or trailing        |
|        |         |     spaces. (TLC #82)                             |
+--------+---------+---------------------------------------------------+
| **10** | Cum     | If the study was approved before 01/01/2002, it   |
|        | ulative | must use the \"Old\" system Gender/Minority       |
|        | Part    | Reporting. The Old System does not use a separate |
|        | icipant | Ethnicity term; therefore the ITPR Ethnicity      |
|        | Accrual | field must remain blank. (TLC #7)                 |
+--------+---------+---------------------------------------------------+
| **11** | Cum     | If the study was approved after 01/01/2002, it    |
|        | ulative | must use the \"New\" system Gender/Minority       |
|        | Part    | Reporting. The New System uses a separate         |
|        | icipant | Ethnicity term; therefore the ITPR Ethnicity      |
|        | Accrual | field must be given a value from its drop-down    |
|        |         | list. (TLC #8)                                    |
+--------+---------+---------------------------------------------------+
| **12** | Cum     | The following fields are mandatory on the         |
|        | ulative | Cumulative Accrual Worksheet:\                    |
|        | Part    | Reporting Period Start Date, Reporting Period End |
|        | icipant | Date, NCI Protocol Number, Registration Number,   |
|        | Accrual | Registration Date, Birth Year, Gender, Race,      |
|        |         | Randomization Number (TLC #9)                     |
+--------+---------+---------------------------------------------------+
| **13** | Cum     | The Reporting Period End Date must be greater     |
|        | ulative | than or equal to all other dates in the report    |
|        | Part    | (TLC #11)                                         |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **14** | Cum     | A patient\'s Registration Date must be earlier    |
|        | ulative | than (or the same as) all other dates associated  |
|        | Part    | with the patient. (i.e. Randomization Date, Begin |
|        | icipant | Run-In Date, Start Agent Date, etc.) (TLC #12)    |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **15** | Cum     | If an End Run-In Date is given for a patient\'s   |
|        | ulative | record, a Begin Run-In Date must also be given.   |
|        | Part    | (TLC #13)                                         |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **16** | Cum     | A Begin Run-In Date must be earlier than (or the  |
|        | ulative | same as) the End Run-In Date (TLC #14)            |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **17** | Cum     | If an End Study Agent Date is given for a         |
|        | ulative | patient\'s record, a Start Study Agent Date must  |
|        | Part    | also be given. (TLC #15)                          |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **18** | Cum     | Start Study Agent Date must be earlier than (or   |
|        | ulative | the same as) End Study Agent Date (TLC #16)       |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **19** | Cum     | If an End Follow-Up Date is given for a           |
|        | ulative | patient\'s record, a Begin Follow-up Date must    |
|        | Part    | also be given. (TLC #17)                          |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **20** | Cum     | Begin Follow-Up Date must be earlier than (or the |
|        | ulative | same as) End Follow-Up Date (TLC #18)             |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **21** | Cum     | End Run-In Date must be earlier than (or the same |
|        | ulative | as) the Start Agent Date (TLC #19)                |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **22** | Cum     | End Study Agent Date must be earlier than (or the |
|        | ulative | same as) the Begin Follow-Up Agent Date (TLC #20) |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **23** | Cum     | Birth Year must be after 1910 (TLC #21)           |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **24** | Cum     | The following fields must contain a value         |
|        | ulative | selected from their drop-down list:\              |
|        | Part    | Gender (Male, Female, or Unknown)\                |
|        | icipant | Race (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) (TLC |
|        | Accrual | #22)                                              |
+--------+---------+---------------------------------------------------+
| **25** | Cum     | The following fields can only contain values      |
|        | ulative | selected from their drop-down list:\              |
|        | Part    | Off Agent Reason\                                 |
|        | icipant | Off Study Reason\                                 |
|        | Accrual | Ethnicity (TLC #23)                               |
+--------+---------+---------------------------------------------------+
| **26** | Cum     | If the study does not assign a Randomization      |
|        | ulative | Number (i.e. the patient record contains \"NA\"   |
|        | Part    | or \"N/A\" in the Randomization Number field)     |
|        | icipant | then Randomization Date field must be blank (TLC  |
|        | Accrual | #24)                                              |
+--------+---------+---------------------------------------------------+
| **27** | Cum     | If the End Study Agent Date is entered then the   |
|        | ulative | Off Agent Reason must also be entered (TLC #25)   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **28** | Cum     | If End Study Agent Date is blank then Off Agent   |
|        | ulative | Reason and Off Agent Comment must also be blank   |
|        | Part    | (TLC #26)                                         |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **29** | Cum     | If Off Study Date is entered then Off Study       |
|        | ulative | Reason must also be entered (TLC #27)             |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **30** | Cum     | If Off Study Date is blank then Off Study Reason  |
|        | ulative | and Off Study Comment must also be blank (TLC     |
|        | Part    | #28)                                              |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **31** | Cum     | If a valid Randomization Number is present in a   |
|        | ulative | patient's record, Start Study Agent Date is       |
|        | Part    | expected. If this value is not yet available, a   |
|        | icipant | comment must be added (preferable in the general  |
|        | Accrual | comments field, column W) to document the reason  |
|        |         | why it is not available. (TLC #29)                |
+--------+---------+---------------------------------------------------+
| **32** | Cum     | If Off Study Date and Begin Run-In Date are       |
|        | ulative | entered then End Run-In Date must also be entered |
|        | Part    | (TLC #30)                                         |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **33** | Cum     | If Off Study Date and Start Agent Date are        |
|        | ulative | entered then End Agent Date must also be entered  |
|        | Part    | (TLC #31)                                         |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **34** | Cum     | If Off Study Date and Begin Follow-Up Date are    |
|        | ulative | entered then End Follow-Up Date must also be      |
|        | Part    | entered (TLC #32)                                 |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **35** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Registration Date. (TLC #43)   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **36** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Randomization Date (TLC #44)   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **37** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Randomization Number for all   |
|        | Accrual | those patient\'s rows must be the same (TLC #45)  |
+--------+---------+---------------------------------------------------+
| **38** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Birth Year (TLC #46)           |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **39** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Gender (TLC #47)               |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **40** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Ethnicity (TLC #48)            |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **41** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Race (TLC #49)                 |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **42** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the Start Study Agent Date must be     |
|        | icipant | entered for all those patient\'s rows (TLC #50)   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **43** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the Start Study Agent Date on each row |
|        | icipant | should define a unique dosing period. (TLC #51)   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **44** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the End Study Agent Date on each row   |
|        | icipant | should define a unique dosing period. (TLC #52)   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **45** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the Off Study information must be      |
|        | icipant | identical on all rows, or must only be present on |
|        | Accrual | the last row. (TLC #53)                           |
+--------+---------+---------------------------------------------------+
| **46** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same Begin Run-In Date (TLC #54)    |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **47** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows belonging to that patient     |
|        | icipant | must have the same End Run-In Date (TLC #55)      |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **48** | Cum     | If a patient has more than one row the Start      |
|        | ulative | Study Agent Date on the row that defines the      |
|        | Part    | earliest dosing period, must be earlier than the  |
|        | icipant | Start Study Agent Date, End Study Agent Date,     |
|        | Accrual | Begin Follow-up Agent Date, End Follow-Up Agent   |
|        |         | Date and Off Study Date for all subsequent rows   |
|        |         | for that patient (TLC #56)                        |
+--------+---------+---------------------------------------------------+
| **49** | Cum     | If a patient has more than one row the End Study  |
|        | ulative | Agent Date on the row that defines the earliest   |
|        | Part    | dosing period, must be earlier than the Start     |
|        | icipant | Study Agent Date, End Study Agent Date, Begin     |
|        | Accrual | Follow-up Agent Date, End Follow-Up Agent Date    |
|        |         | and Off Study Date for all subsequent rows for    |
|        |         | that patient (TLC #57)                            |
+--------+---------+---------------------------------------------------+
| **50** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) all rows (except one) must Off Agent   |
|        | icipant | Reason must be given on all rows except for the   |
|        | Accrual | last row for that patient (TLC #58)               |
+--------+---------+---------------------------------------------------+
| **51** | Cum     | All Cumulative Participant Accrual Records for a  |
|        | ulative | single study must be in accordance with one of    |
|        | Part    | the two Gender/Minority reporting systems. (TLC   |
|        | icipant | #59)                                              |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **52** | Cum     | A warning message will be generated if a patient  |
|        | ulative | has been registered but no Run-in information,    |
|        | Part    | Agent information, or Off-Study information has   |
|        | icipant | been provided within a three month time period.   |
|        | Accrual | (TLC #60)                                         |
+--------+---------+---------------------------------------------------+
| **53** | Cum     | A warning message will be generated if a patient  |
|        | ulative | has been randomized but no Run-in information,    |
|        | Part    | Agent information, or Off-Study information has   |
|        | icipant | been provided within a three month time period.   |
|        | Accrual | (TLC #61)                                         |
+--------+---------+---------------------------------------------------+
| **54** | Cum     | A warning message will be generated if a patient  |
|        | ulative | has ended the run-in phase but no Agent           |
|        | Part    | information, or Off-Study information has been    |
|        | icipant | provided within a three month time period. (TLC   |
|        | Accrual | #62)                                              |
+--------+---------+---------------------------------------------------+
| **55** | Cum     | A warning message will be generated if a patient  |
|        | ulative | has ended the agent phase but no Follow-up or     |
|        | Part    | Off-Study information has been provided within a  |
|        | icipant | three month time period. (TLC #63)                |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **56** | Cum     | A warning message will be generated if a patient  |
|        | ulative | has ended the Follow-Up phase but no Off-Study    |
|        | Part    | information has been provided within a three      |
|        | icipant | month time period. (TLC #64)                      |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **57** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the Begin Follow-Up Date must be       |
|        | icipant | identical on all rows, or must only be present on |
|        | Accrual | the last row. (TLC #65)                           |
+--------+---------+---------------------------------------------------+
| **58** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the End Follow-Up Date must be         |
|        | icipant | identical on all rows, or must only be present on |
|        | Accrual | the last row. (TLC #66)                           |
+--------+---------+---------------------------------------------------+
| **59** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the Begin Run-In Date must be          |
|        | icipant | identical on all rows, or must only be present on |
|        | Accrual | the first row. (TLC #67)                          |
+--------+---------+---------------------------------------------------+
| **60** | Cum     | If a patient has gone on and off agent (i.e. the  |
|        | ulative | patient has multiple rows of data on the Accrual  |
|        | Part    | Worksheet) the End Run-In Date must be identical  |
|        | icipant | on all rows, or must only be present on the first |
|        | Accrual | row. (TLC #68)                                    |
+--------+---------+---------------------------------------------------+
| **61** | Cum     | All patients that appeared on the previous ITPR   |
|        | ulative | must also appear on the current ITPR (TLC #70)    |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **62** | Cum     | All data should be presented in accordance with   |
|        | ulative | HIPAA guidelines. (TLC #71)                       |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **63** | Cum     | If \"Other\" is chosen as the Off Agent Reason    |
|        | ulative | then Off Agent Comment must be entered (TLC #74)  |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **64** | Cum     | If \"Other\" is chosen as the Off Study Reason    |
|        | ulative | then Off Study Comment must be entered (TLC #75)  |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **65** | Cum     | If Randomization Number is not NA or N/A, a       |
|        | ulative | Randomization Date must be given (TLC #78)        |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **66** | Cum     | If a Randomization Date is entered, it must be    |
|        | ulative | earlier than (or the same as) the Begin Run-In    |
|        | Part    | Date, Start Agent Date, Begin Follow-up, Off      |
|        | icipant | Study Date (TLC #80)                              |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **67** | Cum     | All Adverse Event Records must match to an        |
|        | ulative | Accrual Record. Therefore, Adverse Event Rows     |
|        | Adverse | must have a Registration Number and a             |
|        | Events  | Randomization number that are identical to one or |
|        | and     | more records on the Cumulative Participant        |
|        | Cum     | Accrual Worksheet. (TLC #33)                      |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **68** | Cum     | If Off Study Date is entered then Event Status    |
|        | ulative | must also be entered (TLC #34)                    |
|        | Adverse |                                                   |
|        | Events  |                                                   |
|        | and     |                                                   |
|        | Cum     |                                                   |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **69** | Cum     | All AE Onset Date\'s must be greater than (or be  |
|        | ulative | equal to) the patient\'s Registration Date (TLC   |
|        | Adverse | #69)                                              |
|        | Events  |                                                   |
|        | and     |                                                   |
|        | Cum     |                                                   |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **70** | Cum     | If \"AE/SAE\" is chosen as the Off Agent Reason,  |
|        | ulative | there must be a corresponding AE for that patient |
|        | Adverse | in the Cumulative Adverse Events Worksheet (TLC   |
|        | Events  | #72)                                              |
|        | and     |                                                   |
|        | Cum     |                                                   |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **71** | Cum     | If an AE on the Cumulative Adverse Events         |
|        | ulative | Worksheet indicates that a patient has been       |
|        | Adverse | dropped due to the event, the patient must have   |
|        | Events  | an Off Study Reason of \"AE/SAE\" chosen on the   |
|        | and     | Cumulative Participant Accrual Worksheet (TLC     |
|        | Cum     | #73)                                              |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **72** | Cum     | A warning message will be generated if an AE      |
|        | ulative | onset date is greater than the patient\'s off     |
|        | Adverse | study date. (TLC #79)                             |
|        | Events  |                                                   |
|        | and     |                                                   |
|        | Cum     |                                                   |
|        | ulative |                                                   |
|        | Part    |                                                   |
|        | icipant |                                                   |
|        | Accrual |                                                   |
+--------+---------+---------------------------------------------------+
| **73** | Cum     | If the patient has an Event Ended Date then the   |
|        | ulative | Recovery Status must be \"Resolved\" (TLC #76.1)  |
|        | Adverse |                                                   |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **74** | Cum     | If the Recovery Status is \"Resolved\" the        |
|        | ulative | patient must have an Event Ended Date (TLC #76.2) |
|        | Adverse |                                                   |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **75** | Cum     | If the Event Grade for an AE is 5 then Reported   |
|        | ulative | As SAE value should be \"Yes\" (TLC #77)          |
|        | Adverse |                                                   |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **76** | Cum     | If the value \"Blinded\" is selected in the Agent |
|        | ulative | Type column, all of these fields (Agent Dose at   |
|        | Adverse | AE, Dose Units, AND Agent Frequency) must be left |
|        | Events  | blank. (TLC #81)                                  |
+--------+---------+---------------------------------------------------+
| **77** | Cum     | The following fields are mandatory on the         |
|        | ulative | Cumulative Adverse Event Worksheet:\              |
|        | Adverse | Reporting Period Start Date\                      |
|        | Events  | Reporting Period End Date\                        |
|        |         | NCI Protocol Number\                              |
|        |         | Registration Number\                              |
|        |         | Randomization Number\                             |
|        |         | Adverse Event Description\                        |
|        |         | Event Grade\                                      |
|        |         | Event Onset Date\                                 |
|        |         | Reported as SAE\                                  |
|        |         | Blind Broken Due (TLC #35)                        |
+--------+---------+---------------------------------------------------+
| **78** | Cum     | The following fields must contain a value         |
|        | ulative | selected from their drop-down lists:\             |
|        | Adverse | Event Grade\                                      |
|        | Events  | Reported as SAE\                                  |
|        |         | Blind Broken Due to this AE (TLC #36)             |
+--------+---------+---------------------------------------------------+
| **79** | Cum     | The following fields can only contain values      |
|        | ulative | selected from their drop-down lists:\             |
|        | Adverse | Agent Type\                                       |
|        | Events  | Dose Units\                                       |
|        |         | Agent Frequency\                                  |
|        |         | CTC Term\                                         |
|        |         | Event Status\                                     |
|        |         | Dropped due to this AE\                           |
|        |         | (TLC #37)                                         |
+--------+---------+---------------------------------------------------+
| **80** | Cum     | The Reporting Period End Date must be greater     |
|        | ulative | than or equal to all other dates in the report    |
|        | Adverse | (TLC #38)                                         |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **81** | Cum     | Event Onset Date must be less than or equal to    |
|        | ulative | the Event Ended Date (TLC #39)                    |
|        | Adverse |                                                   |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **82** | Cum     | If the CTC Term contains \"Other Specify\' then   |
|        | ulative | the \"CTC Other Specify\" comment field must be   |
|        | Adverse | entered (TLC #40)                                 |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **83** | Cum     | If there is a value in the \"CTC Other Specify\"  |
|        | ulative | field, CTC Term must be one of the \"Other        |
|        | Adverse | Specify\" values. (TLC #41)                       |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+
| **84** | Cum     | If a CTC Term is given, the AE Grade value must   |
|        | ulative | corresponding to the list of valid CTC grades     |
|        | Adverse | described in the CTC Dictionary v2.0 (TLC #42)    |
|        | Events  |                                                   |
+--------+---------+---------------------------------------------------+