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Summary

In certain areas of ClinSpark, specific types of files can be uploaded from a local computer . Certain or added by way of an interface. Depending on the use case, file upload features impose size limits and file type restrictions for these uploadsworkflows. This article outlines the upload commonalities of these features and restrictions.

Study Informed Consent Forms (ICF)

Study specific informed consent documents must be a (added via Study > Configure) must both a valid PDF file and 10MB in size or less. PDF file validity is checked on upload, as the ICF functionality appends a Clinspark barcode onto the file. The upload workflow will not succeed if the file provided is invalid.

ClinSpark will also not allow an ICF to be saved if exceeding the file exceeds the size limit of 10MB.

Warning messages are presented back to the user on save if there are noted issues with the file.

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Data Collection / Form Items

Certain study forms can be configured with an Item ‘file upload’ data type, which when used, allows the ability for a PDF file to be uploaded and attached to the timepointform. This Item data type is used commonly with certain interfaces (such as ECG devices and VCT) that supply PDF documents, and, supporting workflows requiring that may require a user to submit a local document to a study form.

These In versions of ClinSpark prior to 23.3, these PDF files must 10MB in size or less. Validation warnings inline with the Study Item will inform users if attachments do not meet this requirement.

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Starting in ClinSpark 23.3, PDF files up to 100MB in size are accepted.

Volunteer Files

Within a given volunteer record, files uploaded must be a PDF file 10MB in size or less. ClinSpark will not allow an a file to be saved if exceeding the size limit. Warning messages are presented back to the user on save if there are noted issues with the file.

Of note: currently only files with lowercase extension (.pdf) are accepted for upload. Uppercase (.PDF) extension upload will result in an error.

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Medical Dictionaries

Within the Administration > Medical Dictionaries component, qualified users can add MedDRA and WHO Drug dictionaries. These are used for various Medical Coding and volunteer Medical Condition management workflows.

There is no file size limit for dictionary uploads. However, the dictionaries must be in the correct format. Further details on this upload process is and format requirements are specified in this FAQ.

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File Encryption

ClinSpark accepts encrypted PDF files within Data Collection/Form workflows, and also within Volunteer records.

Encrypted PDF files are not accepted for study-specific ICF. Improved support for this is under consideration for a future release of ClinSpark.

Custom File Size/Type Limits

Currently all file size and type restrictions are hard-coded for the features that support file uploads. In a future release of ClinSpark, additional support may be offered allowing customers to customize these limitslimitations, allowing for a more file types and size limitations to be enforced as a system configuration.

Session Timeout and Limited Bandwidth Situations

Large files may take more than a few seconds to upload into ClinSpark. If attempting to upload/attach files in situations where you may be operating with limited internet (upload) speeds, there may be an undesirable user experience.

ClinSpark enforces a session timeout for each user. More information about this can be found in this article: User Management If attempting to upload a file, and the time taken exceeds the session timeout for the current user, the upload may not succeed.

For Study Forms, an attempt to attach files to form Items will timeout after 60 seconds once the ‘Save’ button has been selected. If attempting to upload a file on a study form that exceeds this length of time, the save action may not succeed.

Future releases of ClinSpark will consider improvements file upload workflows and situations that have users operating with limited internet connection (upload) speeds. If customers experience challenges with this functionality, they are encouraged to reach out via service desk ticket.