Documents Metadata

Documents Metadata

Overview of the Documents Metadata

Metadata name
Short description
Value list (yes / no)
Format (Best practice)Metadata dependencies
Testing Facility Number

Unique Document number from testing facility

No

Adama NumberUnique Adama internal doc numberNo

Batch Material NumberIndicator of which batch material is taken for study
Can consists out of different information: plant, country, production date
No

TitleDocument name (Difference between Name and Title fields is that the Name field is what will be shown as the name of the file, while Title will bi shown in the parenthesis next to the Title)No

NameName of the file (Difference between Name and Title fields is that the Name field is what will be shown as the name of the file, while Title will bi shown in the parenthesis next to the Title)No

AuthorDocument AuthorNo

Import DateDate of the Document import into the systemNo

Number of PagesTotal amount of pagesNo

TypeDocument Type (e.g Study Report, Article, LoA, LoS, Certification etc.)Yes

StatusDocument status (can be Draft or Final)Yes

Finalization DateDate, when document receives status = finalNo

Publication DateDate, when document gets publishedNo
If field Type has value Article, Publication date is required
Submission Date CountryA list of Date&Place, when any Dossier containing this Document gets submissioned to AuthoritiesNo

PublishedYes, if Document is accessible to publicityNo

Data Protection ClaimedYes, if Document is accessible to publicityNo

Test on VertebratesYes, if tests were conducted on vertebratesNo

ConfidentialYes, if Document is confidentialNo

LoA
No

ValidityYes, if Document is validNo

Validity ReasonIf validity is not given (validity = no) a reason has to existNo
If Validity Reason is deselected, Validity field is required
GLPYes, if Good Laboratory practice was conductedNo

Sponsor AbbreviationSponsor abbreviationYes
Sponsor Abbreviation is filtered in the select menu depending on the value of the selected Sponsor Name
Sponsor NameFull sponsor company nameYes

OwnerData owner name as abbreviationYes

Co-OwnershipOne or multiple Co-Owners of the dataYes

Testing Facility NameName of the testing facilityYes

If field Type has value Study, Field Trials or Draft, Testing Facility Name is required


Testing Facility Name is filtered in the select menu depending on the value of the selected Testing Facility Country

Testing Facility CountryCountry name of the testing facilityYes
If field Type has value Study, Field Trials or Draft, Testing Facility Country is required
Conduct ReasonDescription why study was conductedNo
If field Type has value Study, Field Trials or Draft, Conduct Reason is required
Document OriginStatement without testingNo
If field Type has any value except Study, Field Trials or Draft, Document Origin is required
SectionsDefines location in the Dossier (Section in the Dossier)Yes

GuidelineName of guideline the Document is followingYes
If field Type has value Study or Field Trials, Guideline is required
Version NumberDocument version numberNo

Version CommentDescription of the changes in the new versionNo

Box NumberStorage location of the physical archived documentNo

RemarksText field allowing the user to enter any commentNo

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