Contact Us

If you still have questions or prefer to get help directly from an agent, please submit a request.
We’ll get back to you as soon as possible.

Please fill out the contact form below and we will reply as soon as possible.

  • Contact Us
  • Home
  • SMS
  • Castor SMS Manual
  • Manual Castor SMS (English) - For research team members

Manage study documents (TMF) in SMS

Contact Us

If you still have questions or prefer to get help directly from an agent, please submit a request.
We’ll get back to you as soon as possible.

Please fill out the contact form below and we will reply as soon as possible.

  • CDMS
    Castor CDMS Manual Castor CDMS Calculations Manual Frequently Asked Questions Articles for Data Managers Castor CDMS Compliance Release Documents
  • eConsent
    Castor eConsent Manual Castor eConsent Compliance Release Documents
  • SMS
    Castor SMS Manual Castor SMS Compliance Release Documents
  • Castor Connect
    Castor Connect Compliance Release Documents Castor Connect Manual Castor Connect - Participant Quick Start Guide
  • Helpdesk
    News Other Resources Castor products knowledge resources
  • Status page
  • Completing a Study
+ More

Add documents to a study

  • Go to the 'Studies' tab.
  • Open the study.
  • Go to the 'TMF' tab.
  • Click on '+ Documents'.
    • Select one or multiple documents that you want to add to the study. Please note that only documents in the following formats can be uploaded: png, jpg, jpeg, gif, bmp, txt, ppt, pptx, xps, eml, msg, xls, xlsx, csv, pdf, doc, docx, docm, odt, rtf, mp4, sps, dat, sav, sql, asp, sas, sas7bdat, xml, xlsb, xlsm, zip.
    • Please be aware that you are not allowed to upload documents which contains sensitive personal data and/or citizen service number. You are also not allowed to upload documents which contains any personal data that can be traced directly or indirectly back to a study participant, such as but not limited to name and hospital information system number.
    • Fill in the required fields per study document. Use the 'Next' and 'Previous' buttons to navigate between the document.Not all fields have to be filled in. For example: In case you don't want to link a document to a specific country or institute (site), you can leave these fields empty.
  • Click 'Done' when all required details have been added.

The document(s) are now added to the study in the corresponding folders.

Upload one document to a specific placeholder

  • Go to the 'Studies' tab.
  • Open the study.
  • Go to the 'TMF' tab.
  • Go to the desired placeholder and click on 'Upload' or use the right mouse click.
  • From here, follow the document upload flow, see above.

The document is now added to the selected placeholder.

View, download, archive and delete documents via List view

  • Go to the 'Studies' tab.
  • Open a study.
  • Go to the 'TMF' tab.
  • Click on 'List' to open the list view
  • Use the right mouse click or action icon to select the action.

View, download, archive and delete documents via Structure view

  • Go to the 'Studies' tab.
  • Open a study.
  • Go to the 'TMF' tab.
  • Click on 'Structure' to open the Structure (folder) view.
  • When clicking once on a document, a drawer on the right side will open that displays the document details. Use the icons at the top of the drawer to download, archive or delete the document.
  • When clicking twice on a document, a detailed view for that document will open. Use the icons at the right top to download, archive or delete the document. There is a navigation on the left side of the screen to go to the document preview of document specific audit trail.

Find specific study documents

  • Go to the 'Studies' tab.
  • Open a study.
  • Go to the 'TMF' tab.
  • Click on 'Filter' to open the filter menu.
  • Select the desired filters and click 'Apply' to activate the filters.
    • Document location: Show the active, archived and/or deleted documents
    • Required: Only show the document types that are required in this study status
    • Country: Only show the documents that are linked to specific countries
    • Institute: Only show the documents that are linked to specific institutes (sites)
    • Show placeholders: Show placeholders or only the documents

Was this article helpful?

Yes
No
Give feedback about this article

Related Articles

  • Create a new study in SMS
  • Manage study documents in SMS
  • Submit study for approval in SMS
  • Overview of the approval requests in SMS
ISO 27001
FDA - 21 CFR part 11
ICH GCP compliant
HIPAA compliant
CDISC
ISO 9001
gdpr compliant

Products & Industries

  • Electronic Data Capture (EDC)
  • ePRO
  • eConsent
  • Decentralized Clinical Trials (DCT)
  • Clinical Data Management
  • Medical Device & Diagnostics
  • Biotech & Pharma
  • CROs
  • Academic Research

Resources

  • Thought Leadership
  • Blog
  • Castor Academy
  • Knowledge Base

 

Company

  • About Us
  • Careers
  • News
  • Contact Support
  • Contact Us

Legal & Compliance

  • Terms of Use
  • Privacy & Cookie Statement
  • Responsible Disclosure Policy
  • Good Clinical Practice (GCP)
  • ISO Compliance Certificates
  • GDPR & HIPAA Compliance
  • Security Statement

© 2022, Castor. All Rights Reserved.

Follow us on social media


Knowledge Base Software powered by Helpjuice

Definition by Author

0
0
Expand