eTMF

The eTMF (Electronic Trial Master File) API enables you to manage clinical trial documentation programmatically. Use this API to query study details, retrieve filing levels, list artifacts and milestones, and import documents into your studies.

Base URL

https://{domain}.egnyte.com/pubapi/v1/etmf

Authentication

All requests require an OAuth 2.0 Bearer token in the Authorization header:

Authorization: Bearer {access_token}

See Authentication for details on obtaining a token with the Egnyte.etmf scope.

List Studies

Retrieve all studies the authenticated user has access to.

Request

GET /pubapi/v1/etmf/studies

Path Parameters

This endpoint does not require path parameters.

Query Parameters

This endpoint does not require query parameters.

Example Request

curl -i -X GET "https://{domain}.egnyte.com/pubapi/v1/etmf/studies" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN"

Response

200 OK

Example Response

{
  "studies": [
    {
      "systemId": "eee92526-53ce-45be-bdce-7263567c9e78",
      "id": "DEM-81",
      "name": "Demo 81 Study",
      "description": "Acme Tx is conducting a study to evaluate the impact of DEM-81 on...",
      "status": "ACTIVE"
    }
  ]
}

List Filing Levels

Retrieve the filing level hierarchy (trial, countries, and sites) for a specific study.

Request

GET /pubapi/v1/etmf/studies/{studyId}/filing-levels

Path Parameters

Example Request

curl -i -X GET "https://{domain}.egnyte.com/pubapi/v1/etmf/studies/{studyId}/filing-levels" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN"

Response

200 OK

Example Response

{
  "trial": {
    "systemId": "2f47005e-76d1-42e7-857c-926ca5723e18",
    "status": "ACTIVE",
    "countries": [
      {
        "systemId": "5ccfd52a-75f9-49c5-b2e0-177862699ed0",
        "code": "POL",
        "status": "ACTIVE",
        "sites": [
          {
            "systemId": "ab650679-ac09-4e1e-afd9-13de225ec4af",
            "id": "WAW_01",
            "status": "ACTIVE"
          }
        ]
      }
    ]
  }
}

List Artifacts and Milestones

Retrieve available artifacts and milestones for a specific filing level within a study.

Request

GET /pubapi/v1/etmf/studies/{studyId}/artifacts

Path Parameters

Query Parameters

Example Request

curl -i -X GET "https://{domain}.egnyte.com/pubapi/v1/etmf/studies/{studyId}/artifacts?filingLevel=trial&filingLevelId={filingLevelId}" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN"

Response

200 OK

Example Response

{
  "artifacts": [
    {
      "referenceModelArtifactId": "001",
      "number": "01.01.01",
      "name": "Trial Master File Plan",
      "isUnblinded": false,
      "milestoneNumber": 2
    }
  ],
  "milestones": [
    {
      "id": "aa9b50b7-f8ad-4cdd-a401-a6d23ee06568",
      "name": "Clinical Infrastructure Ready",
      "number": 2,
      "status": "ACTIVE"
    }
  ]
}

List Documents

Retrieve documents for a specific filing level with optional filtering by zone, artifact, and status. Supports pagination.

Request

POST /pubapi/v1/etmf/studies/{studyId}/documents/listing

Path Parameters

Request Body

Example Request

curl -i -X POST "https://{domain}.egnyte.com/pubapi/v1/etmf/studies/{studyId}/documents/listing" \
     -H "Content-Type: application/json" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN" \
     -d '{ "filingLevel": { "type": "SITE", "systemId": "b53884cf-2bc0-4830-abba-a54c67c25a65" }, "zone": "02 Central Trial Documents", "artifact": "02.01.01 Investigator'

Response

200 OK

Example Response

{
  "documents": [
    {
      "studyId": "ab650679-ac09-4e1e-afd9-13de225ec4af",
      "id": "ab650679-ac09-4e1e-afd9-13de225ec4af",
      "artifact": {
        "artifactNumber": "02.01.01",
        "artifactName": "Investigator's Brochure",
        "sectionNumber": "02.01",
        "sectionName": "Product and Trial Documentation",
        "zoneNumber": "02",
        "zone": "Central Trial Documents",
        "referenceModelArtifactId": "31",
        "isUnblinded": false
      },
      "milestone": {
        "name": "Clinical Infrastructure Ready",
        "number": 2,
        "id": "45f8cb40-0d8e-4f82-89c3-3708e4b0210d"
      },
      "filingLevel": {
        "type": "TRIAL"
      },
      "file": {
        "name": "Investigator Brochure v1 - 2024-02-14.docx",
        "entryId": "17c79408-6faf-4ba4-8be1-0b77a7511e60",
        "groupId": "aa5f47a4-4a02-425b-88ec-dcbe7fa7c2c2"
      },
      "qualityControl": {
        "dueOn": "2025-04-12T14:08:14.812Z",
        "status": "DRAFT"
      }
    }
  ],
  "offset": 0,
  "hasMore": true
}

Add Documents

Import a document into a study. The file must already exist in the Egnyte file system before calling this endpoint.

Request

POST /pubapi/v1/etmf/studies/{studyId}/documents

Path Parameters

Request Body

Example Request

curl -i -X POST "https://{domain}.egnyte.com/pubapi/v1/etmf/studies/{studyId}/documents" \
     -H "Content-Type: application/json" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN" \
     -d '{
  "filingLevel": {
    "systemId": "aa9b50b7-f8ad-4cdd-a401-a6d23ee06568",
    "type": "TRIAL"
  },
  "classification": {
    "referenceModelArtifactId": "001",
    "milestoneId": "c8cfa0dd-dda3-4089-962d-3d33bb6ae448"
  },
  "sourceFile": {
    "groupId": "35ed2e11-35e8-4712-b78f-98aceb780ef8"
  }
}'

Response

200 OK

Example Response

{
  "id": "aa9b50b7-f8ad-4cdd-a401-a6d23ee06568",
  "file": {
    "groupId": "35ed2e11-35e8-4712-b78f-98aceb780ef8",
    "entryId": "5c8598b6-1ab4-45e5-b534-4b60caeddabd",
    "path": "/Shared/__eTMF__/STD-001_STAGING/Trial Binder/Artifacts/01 First Country RA Approval/02 Central Trial Documents/02.01 Product and Trial Documentation/02.01.01 Investigator's Brochure/example.pdf"
  }
}

Error Codes

Code Examples

List Studies

curl -i -X GET "https://{domain}.egnyte.com/pubapi/v1/etmf/studies" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN"

Add Document

curl -i -X POST "https://{domain}.egnyte.com/pubapi/v1/etmf/studies/eee92526-53ce-45be-bdce-7263567c9e78/documents" \
     -H "Content-Type: application/json" \
     -H "Authorization: Bearer YOUR_ACCESS_TOKEN" \
     -d '{
  "filingLevel": {
    "systemId": "aa9b50b7-f8ad-4cdd-a401-a6d23ee06568",
    "type": "TRIAL"
  },
  "classification": {
    "referenceModelArtifactId": "001",
    "milestoneId": "c8cfa0dd-dda3-4089-962d-3d33bb6ae448"
  },
  "sourceFile": {
    "groupId": "35ed2e11-35e8-4712-b78f-98aceb780ef8"
  }
}'

Related Resources

• Authentication — How to obtain OAuth tokens with the Egnyte.etmf scope
• File System API — Upload and manage files before importing them into eTMF
• Best Practices — Rate limiting, pagination, and error handling strategies