Uploading Drafts

Drafts can be imported into TrialGrid either by uploading an ALS file or by importing direct from Medidata Rave.

Upload a Draft from an Architect Loader Spreadsheet (ALS) File

To import a Draft from an ALS spreadsheet, export the Draft from Medidata Rave using the Draft Download button from Architect. This will provide you with a zipped (compressed) Architect Loader Spreadsheet (ALS). To load this ALS (or an ALS created directly in Excel) into TrialGrid:

1. Click the Upload Draft button from the Projects Draft Management page and enter a new name for the Draft. If you do not wish to rename the Draft then leave the Name field empty, TrialGrid will take the name from the Cover page of the Architect Loader Spreadsheet.

2. Click the Choose File button and select the file you downloaded from Medidata Rave or any other Architect Loader Spreadsheet you wish to upload.

  1. Click “Upload” and the upload process will start.

The upload process occurs in two stages: First importing the file into a secure storage area where it is encrypted at rest. Second, the Architect Loader Spreadsheet is decompressed (if zipped) and then read. Edit checks are converted from the ALS format and into the TrialGrid Infix check format. Compatibility checks between the ALS and the configuration for the URL are performed and warnings are shown to the user if there is a potential issue (e.g. the Draft references an EDC role that is not set up or is not active in the URL Configuration.

Upload a Draft direct from Medidata Rave Architect

A Draft can be imported direct from Rave Architect by using the Import Draft functionality:

  1. Click the Import Draft button from the Projects Draft Management page.

  2. Select either import via iMedidata or via Rave Classic.

  3. Enter the URL of the Rave or iMedidata intance you wish to import from. This should be the full URL of the instance (e.g. https://innovate.mdsol.com or https://innovate.imedidata.com).

  4. Enter a username and password for the Rave or iMedidata account. Note that TrialGrid does not store this username/password in the TrialGrid database. It is used only for your login session - when you log out these credentials will be forgotten by the system and you will need to re-enter next time you login.

  5. Click the Get Projects button to have TrialGrid fetch a list of projects available to this user from Rave Architect or from iMedidate. Note that iMedidata studies have the Rave URL they are associated with listed as part of the project name (e.g. “Mediflex (demo.mdsol.com)” and “Mediflex (innovate.mdsol.com)” )

  6. Select the Project you wish to import from. The list of Drafts to import from may take a few seconds to update. Pick Draft or Version you wish to import. Note that Versions have the CRF version identifier after their name. e.g. “Draft 1 (Version 67)”

  7. Click the “Import Draft” button. TrialGrid then pulls this Draft from Rave Architect using the credentials you supplied in step 4. Once downloaded import proceeds the same as in Upload a Draft from an ALS File above.

Notes about the Upload and Import process

Note

Once uploaded a Draft can be downloaded again at any time. Deleting the Draft, Project or URL will delete all copies of the Draft, draft upload and Architect Loader Spreadsheet file.

Note

The upload process will renumber ordinals on Forms, Fields, Check Steps, etc so that they are consecutive starting from 1. Rave does not preserve a consecutive order so its possible to have gaps in the Ordinals. If any Ordinals or StepOrdinals are missing or contain non-integer values, the upload process will display a warning and will place them first in the ordering.

Note

Some versions of Rave will create an almost, but not quite, empty row on a worksheet which otherwise has no rows. For example, if there are no Data Dictionaries, Rave might export ‘False’ in the Specify column of row 2. TrialGrid will ignore this row, similarly for Derivations and CheckActions.

The upload process performs extensive validity checking on the ALS and will report errors or warnings during the upload. If there are any errors then the draft will not be uploaded into TrialGrid. Warnings will be reported but will not prevent the upload from completing. We recommend that warnings are reviewed carefully to ensure the uploaded draft is as expected. The list of errors and warnings can be printed, copied to the clipboard or exported to a text file, Excel or pdf.

ALS Upload Verification

TrialGrid performs some verification steps on Drafts imported or uploaded.

CRF Draft Verification

Type

Example message / Description

Error

Could not read file - maybe the file is in Excel 97-2004 Workbook (.xls) format

Please make sure the file is saved in Excel 2004 XML Spreadsheet (.xml) format

If the file is not a valid Excel 2004 XML Spreadsheet (.xml) TrialGrid will not import it.

Error

Could not find CRFDraft tab

If the ALS does not contain a CRFDraft worksheet TrialGrid will not import it.

Error

No rows on CRFDraft tab

If the CRFDraft worksheet has no rows TrialGrid will not import it.

Error

Multiple rows on CRFDraft tab

If the CRFDraft worksheet has more than one row TrialGrid will not import it.

Warning

Draft “Draft A” already exists. The new Draft is named “Draft A (1)”

If there is already a Draft with the same name within this TrialGrid project as that in the DraftName column in the ALS then TrialGrid will rename the newly created Draft by appending a number, starting at 1 but using a higher number if “Draft A (1)” also already exists.

Warning

Folder with OID SUBJECT found at row 3. SUBJECT Reserved by Rave, Row not imported

Rave reserves the Folder OID “SUBJECT” for its own use (Forms at the Subject level). If an ALS includes a Folder with this OID, the Folder is ignored.

Warning

Folder with FolderName SUBJECT found at row 3. SUBJECT Reserved by Rave, Row not imported

Rave reserves the Folder Name “SUBJECT” for its own use (Forms at the Subject level). If an ALS includes a Folder with this Name, the Folder is ignored.

Error

Could not find PrimaryForm ‘F1’

If the PrimaryForm on the CRFDrafts worksheet does not exist on the Forms worksheet, TrialGrid will report an error.

Error

Could not find DefaultMatrix ‘M1’

If the PrimaryForm on the CRFDrafts worksheet does not exist on the Forms worksheet, TrialGrid will report an error.

Column Verification

Type

Example message / Description

Warning

Sheet Folders : Did not find expected column TargetDays

TrialGrid checks that the ALS contains all expected columns in each worksheet present in the ALS.

An ALS more than 200 columns (some are optional, see below).

See the ALS Draft Upload Specification for a list of all 200+ columns checked by TrialGrid.

TrialGrid does a case-insentive match on column name, ie. ‘TargetDays’ is the same as ‘Targetdays’. This is necessary because older versions of Rave exported the ALS with ‘Targetdays’ in the Folders worksheet whereas newer ones export ‘TargetDays’.

Some columns are not used by TrialGrid and are not reported as warnings if not present, ‘NeedsRestesting’ for example.

Row Identifier Verification

See the ALS Draft Upload Specification for more information about the verification of row identifiers for each of the 20 worksheets in an ALS.

Type

Example message / Description

Warning

Sheet Forms : Row 10 Column 1 Value ‘’ for column FormOID - Required Value missing. Row was ignored

Most ALS worksheets must have a value present in the column(s) which uniquely identifies the object in that row. If there is no value present in the identifier column TrialGrid will report a warning and will not import that row.

Warning

Sheet Fields : Row 5 : Key ‘VISIT_VISITIM’ already exists. Row not imported

TrialGrid will check for duplicate row identifiers, will generate a warning if there is a duplicate and will only import the first one.

Error

Could not find Form ‘vst’, referenced by Field ‘VISITDT’

TrialGrid checks that cross-references between worksheets are valid, for example that the FormOID specified in the Fields worksheet exists in the Forms worksheet. If a cross-reference does not exist TrialGrid will report an error and the Draft will not be imported.

Cell Value Verification

Type

Example message / Description

Warning

Sheet Forms : Row 10 Column 2 Value ‘SCRN’ for column Ordinal - Value ‘SCRN’ is not an integer

Sheet Forms : Row 5 Column 4 Value ‘Y’ for column DraftFormActive - Value ‘Y’ is not an allowed value. Expected one of TRUE,FALSE

Sheet UnitDictionaryEntries : Row 2 Column 4 Value ‘A’ for column ConstantA - A is not numeric

TrialGrid will validate that the contents of each cell are appropriate for that column, for example that Ordinal columns contain integers. If the content does not match the expected specification TrialGrid will generate a warning and will not import a value for that cell. If there are no other errors preventing the import of that row then the object (Form, etc) will be imported, but with an empty value for that cell.

See the ALS Draft Upload Specification for more details of the validation applied to each of the 200+ columns in an ALS.

Warning

Field VSDT has an invalid Ordinal

Form VSD has an invalid Ordinal

Folder SCRN has an invalid Ordinal

Check VSDT_AGE has a Check Step with an invalid Step Ordinal

Data Dictionary SEVERITY Entry SEVERE has an invalid Ordinal

Unit Dictionary LBTEST Entry WBC has an invalid Ordinal

Derivation AGE has a Derivation Step with an invalid Step Ordinal

TrialGrid will check that Ordinals are integer values. See note above about re-ordering of non-consecutive Ordinals.

Empty Object Verification

Type

Example message / Description

Warning

Data Dictionary SEVERITY has no entries

Unit Dictionary LBTEST has no entries

Check AGE_RANGE has no steps

Derivation AGE has no steps

TrialGrid will generate a warning if objects are ‘empty’.

URL Configuration Warnings

Type

Example message / Description

Warning

Marking Group Site from System not present in URL Configuration

TrialGrid checks whether Marking Groups used in Edit Check Actions exist in the URL Configuration within TrialGrid. Diagnostic 00019 also reports missing Marking Groups and has a one-click Fix to add them to the URL Configuration.

Warning

Review Group DM not present in URL Configuration

TrialGrid checks whether Review Groups used in Edit Check Actions exist in the URL Configuration within TrialGrid. Diagnostic 00018 also reports missing Marking Groups and has a one-click Fix to add them to the URL Configuration.

Warning

EDC Role Investigator not present in URL Configuration

TrialGrid checks whether EDC Roles used in Form and Field View/Entry Restrictions exist in the URL Configuration within TrialGrid. Diagnostic 00021 also reports missing Marking Groups and has a one-click Fix to add them to the URL Configuration.

Matrix Verification

Type

Example message / Description

Warning

Could not find a Matrix Worksheet with a name like TEST_1 or TEST1

TrialGrid will look for a matrix worksheet for each Matrix listed on the Matrices worksheet and raise a warning if not found.

If a MatrixName contains an underscore, like ‘TEST_1’, Rave will sometimes export a worksheet for that Matrix without the underscore in the worksheet name, so the worksheet name might be ‘Matrix1#TEST_1’ or ‘Matrix1#TEST1’. TrialGrid searches for both.

Warning

Too many worksheets (2) with names like MatrixX#PRIMARY taking Matrix2#PRIMARY ignoring others

If TrialGrid finds more than one worksheet for a Matrix, for example if the ALS contains sheets ‘Matrix2#PRIMARY’ and ‘Matrix4#PRIMARY’ then TrialGrid will generate a warning and select the first Matrix worksheet to import.

Warning

Could not find Form with OID VST in Matrix PRIMARY

If a Matrix worksheet contains a row with a Form OID which does not exist on the Forms worksheet, TrialGrid will report a warning.

Warning

Could not find Folder with OID SCRN in Matrix PRIMARY

If a Matrix worksheet contains a column with a Folder OID which does not exist on the Folder worksheet, TrialGrid will report a warning.

Warning

Sheet Matrix2#PRIMARY : Row 4 Colum 3 Value ‘Z’ - Should be ‘X’ or empty

Rave expects an ‘X’ character in the Folder/Form cell of a Matrix worksheet. If TrialGrid finds any value other than ‘X’, ‘x’ or empty it will generate a warning and treat the cell as empty.