Summary
In certain areas of ClinSpark, specific types of files can be uploaded from a local computer or added by way of an interface. Depending on the use case, file upload features impose size and file type restrictions for these workflows. This article outlines the commonalities of these features and restrictions.
Study Informed Consent Forms (ICF)
Study specific informed consent documents (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 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.
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 attached to the form. This Item data type is used commonly with certain interfaces (such as ECG devices and VCT) that supply PDF documents, and, supporting workflows that may require a user to submit a local document to a study form.
In all 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.
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 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.
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 and format requirements are specified in this FAQ.
File Encryption
ClinSpark accepts encrypted PDF files within Data Collection/Form workflows, and also within Volunteer records.
However, 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 limitations, allowing for a more file types and size limitations to be enforced as a system configuration.