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daveih committed Dec 9, 2024
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73 changes: 47 additions & 26 deletions README.md
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Expand Up @@ -54,6 +54,8 @@ The workbook consists of several sheets each with a dedicated purpose. All sheet
- Study sheet
- Study Identifiers sheet
- Study Amendments sheet
- Study Amendments Changes sheet
- Study Amenedment Impact sheet
- Study Design sheet
- Study Design Arms sheet
- Study Design Epochs sheet
Expand Down Expand Up @@ -141,6 +143,12 @@ Some entries can include "tags" that allow the text to reference structured cont

An example of Templated Text is `Subjects shall be between <usdm:tag name="min_age"/> and <usdm:tag name="max_age"/>` where the min and max ages will be inserted using the dictionary entries that refer to particular attribute values from within the structured parts of the model.

### Geographic Scopes & Enrollment

Geographic Scopes appear in a few of the sheets. These take the form `Global`, `Region: <region>` or , `Country: <country>`. Regions and Countries are taken from the ISO3166 value set. Examples are `Global` or `Region: Europe, Country: USA`. Where multiple codes are needed then the values are separated by commas. Note, if a global entry is specified then no other values are required and will be ignored.

In some cases (subject recruitment) values are associated with the scopes. The enrollment data is of the form: `Global: <enrollment>`, `Region: <region>=<enrollment>` or , `Country: <country>=<enrollment>`. The enrollment is either a percentage or an absolute value. Regions and Countries are taken from the ISO3166 value set. Examples are `Global: 65%` or `Region: Europe=15, Country: USA=20%`. Where multiple codes are needed then the values are separated by commas. Note, if a global entry is specified then no other values are required and will be ignored.

### Sheet Descriptions

The sheet descriptions detail the fields found within each sheet and the details of the data required. Note:
Expand Down Expand Up @@ -186,9 +194,7 @@ A header row in row 16 followed by repeating rows from row 17, containing a seri
| D | label | A date label | Text string|
| E | type | the type of date | CDISC code reference |
| F | date| The date | Date field, dd/mm/yyyy |
| H | scopes | The geographic scopes for the date | Geographic scoped, see below |

The geographic is of the form: `Global`, `Region: <region>` or , `Country: <country>`. Regions and Countries are taken from the ISO3166 value set. Examples are `Global` or `Region: Europe, Country: USA`. Where multiple codes are needed then the values are separated by commas. Note, if a global entry is specified then no other values are required and will be ignored.
| H | scopes | The geographic scopes for the date | Geographic scope |

### Study Identifiers Sheet

Expand All @@ -210,7 +216,6 @@ A header row in row 1 followed by repeating rows from row 2, each containing a s
| F | studyIdentifier | The identifier for the study | Text string |
| G | organisationAddress, organizationAddress or address | The organisation address | Address |


### Study Amendments Sheet

#### Sheet Name
Expand All @@ -228,29 +233,45 @@ A header row in row 1 followed by repeating rows from row 2, containing a study
| C | substantialImpact | True or false value indicating if the amendment is substantial | Boolean |
| D | primaryReason | Primary reason for the amendment | CDISC code reference |
| E | secondaryReasons | Secondary reasons for amendment. Multiple values can be supplied separated by a comma | CDISC code reference |
| F | enrollment | The current state of subject enrollment, either global, regional or country | Geographic scoped, see below |

The enrollment data is of the form: `Global: <enrollment>`, `Region: <region>=<enrollment>` or , `Country: <country>=<enrollment>`.
The enrollment is either a percentage or an absolute value. Regions and Countries are taken from the ISO3166 value set. Examples are `Global: 65%` or `Region: Europe=15, Country: USA=20%`. Where multiple codes are needed then the values are separated by commas. Note, if a global entry is specified then no other values are required and will be ignored.

The primary and secondary reasons should be set to one (primary) or one or more (secondary) values from the following reasons:

- Regulatory Agency Request To Amend
- New Regulatory Guidance
- IRB/IEC Feedback
- New Safety Information Available
- Manufacturing Change
- IMP Addition
- Change In Strategy
- Change In Standard Of Care
- New Data Available (Other Than Safety Data)
- Investigator/Site Feedback
- Recruitment Difficulty
- Inconsistency And/Or Error In The Protocol
- Protocol Design Error
- Other
- Not Applicable
| F | enrollment | The current state of subject enrollment, either global, regional or country | Geographic scope with enrollment |

### Study Amendments Changes Sheet

#### Sheet Name

`amendmentChanges`

#### Sheet Contents

A header row in row 1 followed by repeating rows from row 2, containing a study amendment changes:

| Column | Column Name | Purpose | Format and Values |
| :--- | :--- | :--- | :--- |
| A | amendment | The amendment to which the change belongs, references the main amendment sheet | Integer |
| B | name | Name of the change | Text string |
| C | description | Description for the change | Text string |
| D | label | Change label. Default value is '' | Text string |
| E | rationale | The rationale for the change | Text string |
| F | summary | Summary of the change | Text string |
| G | sections | Section references | Comma separated text string consisting of `<section number>: <description of change>` |

### Study Amendments Impact Sheet

#### Sheet Name

`amendmentImpact`

#### Sheet Contents

A header row in row 1 followed by repeating rows from row 2, containing a study amendment impacts:

| Column | Column Name | Purpose | Format and Values |
| :--- | :--- | :--- | :--- |
| A | amendment | The amendment to which the change belongs, references the main amendment sheet | Integer |
| B | text | Text describing the impact of the amendment | Test string |
| C | substantial | Indicates the change is substantial | Boolean |
| D | type | The type of impact | CDISC code referernce |

### Study Design sheet

#### Sheet Name
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2 changes: 1 addition & 1 deletion tests/test_integration.py
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Expand Up @@ -5,7 +5,7 @@
from bs4 import BeautifulSoup
from uuid import UUID

SAVE_ALL = True
SAVE_ALL = False

def save_error_csv(file, contents):
writer = csv.DictWriter(file, fieldnames=['sheet','row','column','message','level'])
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