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Update the read me
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@daveih
daveih committed Feb 6, 2025
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Expand Up @@ -173,21 +173,18 @@ The study sheet consists of two parts, the upper section for those single values

For the single values, the keyword is in column A while the value is in column B.

| Row | Row Name | Purpose | Format and Values |
| :--- | :--- | :--- | :--- |
| 1 | studyTitle | The study title | Text string |
| 2 | studyVersion | String version | Text string |
| 3 | studyType or type | The study type | CDISC code reference |
| 4 | studyPhase | The study phase | CDISC code reference |
| 5 | studyAcronym | The study acronym | Text string |
| 6 | studyRationale | the study rationale | Text string |
| 7 | businessTherapeuticAreas | The set of business therapuetic area codes | External CT code format. Likely filled with sponsor terms |
| 8 | briefTitle | The brief title | Text string |
| 9 | officialTitle | The officiall title | Text string|
| 10 | publicTitle | The public title | Text string|
| 11 | scientificTitle | The scientific title | Text string|
| 12 | protocolVersion | The version of the protocol | Text string |
| 13 | protocolStatus | The status | CDISC code reference |
| Key Word | Purpose | Format and Values |
| :--- | :--- | :--- |
| studyVersion | String version | Text string |
| studyAcronym | The study acronym | Text string |
| studyRationale | the study rationale | Text string |
| businessTherapeuticAreas | The set of business therapuetic area codes | External CT code format. Likely filled with sponsor terms |
| briefTitle | The brief title | Text string |
| officialTitle | The officiall title | Text string|
| publicTitle | The public title | Text string|
| scientificTitle | The scientific title | Text string|
| protocolVersion | The version of the protocol | Text string |
| protocolStatus | The status | CDISC code reference |

A header row in row 16 followed by repeating rows from row 17, containing a series of dates:

Expand Down Expand Up @@ -319,23 +316,26 @@ A header row in row 1 followed by repeating rows from row 2, containing a study

The study design sheet consists of two parts, the upper section for those single values and then a section for the arms and epochs.

For the single values, the keyword is in column A while the value is in column B. Some rows can repeat
For the single values, the keyword is in column A while the value is in column B.

| Row Name | Purpose | Format and Values | Repeat |
| :--- | :--- | :--- | :--- |
| studyDesignName or name | Study design name | Text string | No |
| studyDesignDescription or description | Study design description | Text string | No |
| label | Study design label. Default value is '' | Text string | No |
| therapeuticAreas | Set of therapeutic area codes | Set of external CT references, comma separated | No |
| studyDesignRationale | Study design rationale | Text string | No |
| studyDesignBlindingScheme | Code for the blinding scheme | CDISC code reference | No |
| trialIntentTypes | Codes for the trial intent types | Comma separated CDISC code references | No |
| trialTypes | Code for the trial type | CDISC code reference| No |
| interventionModel | | CDISC code reference | No |
| masking | A masking role | Takes form of Role=description where the role is a CDISC Code Reference | Yes |
| characteristics | Set of characteristics | Set of CDISC code references | No |
| mainTimeline | Name of main timeline sheet | This must be present | No |
| otherTimelines | Names of other timeline sheeText string | Commma separated list of sheet names. Can be empty | No |
| Key Word | Purpose | Format and Values |
| :--- | :--- | :--- |
| studyDesignName or name | Study design name | Text string |
| studyDesignDescription or description | Study design description | Text string |
| label | Study design label. Default value is '' | Text string |
| studyType | The study type. This is where Interventional / Observation selection is made | CDISC code reference |
| studyPhase | The study phase | CDISC code reference |
| therapeuticAreas | Set of therapeutic area codes | Set of external CT references, comma separated |
| studyDesignRationale | Study design rationale | Text string |
| studyDesignBlindingScheme | Code for the blinding scheme | CDISC code reference |
| trialIntentTypes | Codes for the trial intent types | Comma separated CDISC code references |
| trialTypes | Code for the trial type | CDISC code reference|
| interventionModel | | CDISC code reference |
| characteristics | Set of characteristics | Set of CDISC code references |
| timePerspective | Observation study time perspective | CDISC code reference |
| samplingMethod | Sampling method | CDISC code reference |
| mainTimeline | Name of main timeline sheet | This must be present |
| otherTimelines | Names of other timeline sheets | Commma separated list of sheet names. Can be empty |

For the arms and epochs, a simple table is required. The table starts in row 12 and can consists of a header row and 1 or more arm rows.

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