From 947792290a2cb29efb4d49a4c39e658e2983e3c1 Mon Sep 17 00:00:00 2001 From: Dave Iberson-Hurst Date: Thu, 6 Feb 2025 16:23:08 +0100 Subject: [PATCH] Update the read me --- README.md | 62 +++++++++++++++++++++++++++---------------------------- 1 file changed, 31 insertions(+), 31 deletions(-) diff --git a/README.md b/README.md index 784c3b39..1ec772a7 100644 --- a/README.md +++ b/README.md @@ -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: @@ -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.