Manage documents

What this is, and who it is for#

The document register holds the study's documents (the protocol, amendments, the consent form, plans, correspondence) and each site's documents, with their versions, so that the exact document in force on a given date can be produced. The protocol is the one the system insists on: a version cannot be submitted to UAT with no protocol on file. This page is the task; every option, file rule and status is on the Documents reference.

Held by: Organization Admin, Project Manager, Data Manager, Regulatory Manager (document.write).

Held by: Organization Admin, Project Manager, Regulatory Manager (document.manage).

Where to find it#

Study → Documents (study level, outside any workspace): Protocol, informed consent, regulatory, and study documents — version-controlled, access-controlled, and audit-ready. The page counts Total, Approved, Draft, Archived and Types and lists the documents (Document, Status, Version, Uploaded, Size, Actions) with a search (Search documents…) and a type filter (All types). A site's own documents are under Sites → the site → Documents.

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1. The site's documents, with the study-wide ones that are visible everywhere.
2. Adds a document to this site.

What you can do#

1. Upload. Choose Upload document: Add a study document. The file uploads directly to secure object storage; metadata and version history are recorded here. Give the Title (for example Study Protocol v2.0), the Type, the Version label (v1.0), an optional Description (a summary or change note) and the File. A toast says Uploaded {name}. The file goes straight to the object store; the server then checks that its content is what its name says.
2. Open a document to see its Metadata, Current version, Description, a Preview (PDF and common images; other files download) and its Version history (the current version is marked Current).
3. Add a version by uploading a replacement: it becomes the current version; the earlier ones stay retrievable.
4. Approve a document (making it the version in force) or Archive it (superseded or withdrawn, kept). Documents start as Draft.
5. Download any version.

A document can be registered while the study is still in Setup; the protocol is uploaded there, before any data exists.

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1. Opens the upload dialog.

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Every option#

The document types (protocol, protocol amendment, investigator brochure, ICF, CRF specification, data management plan, monitoring plan, statistical analysis plan, SOP, training material, regulatory document, site document, other), the statuses, the largest file (100 MB by default), the accepted file kinds, the content check (a program is refused under any name) and what each action records are on the Documents reference.

What the system records#

document.uploaded, document.version_added, document.metadata_updated, document.approved, document.archived, document.downloaded, document.previewed, each with the person and the time. A refused file leaves no trace in the register. See Audit events.

What you cannot do, and why#

• Delete or overwrite a document. Versions are added; documents are archived.
• Upload a program, or a file that is not what its name says, or one over the limit.
• Sign a document electronically, or find out who read it: downloads and previews are audited; there is no read receipt.
• Use the register as a trial master file. It has no TMF structure, expected-document checklist or completeness scoring.
• Submit a version to UAT without a protocol on file.

Compliance Q&A#

Related#

Documents reference · Build a study · Regulatory Manager