Summary
In certain areas of ClinSpark, files can be uploaded from a local computer. Certain features impose size limits and file type restrictions for these uploads. This article outlines the upload features and restrictions.
Study ICF
Study specific informed consent documents must be a PDF file 10MB in size or less. ClinSpark will not allow an ICF to be saved if exceeding the size limit.
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 timepoint. This Item data type is used commonly with certain interfaces (such as ECG devices and VCT) that supply PDF documents, and, supporting workflows requiring a user to submit a document to a study form.
These files must 10MB in size or less.
Volunteer Files
Within a given volunteer record, files uploaded must be a PDF file 10MB in size or less. ClinSpark will not allow an file to be saved if exceeding the size limit.
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 process is specified in this FAQ.
File Encryption
ClinSpark accepts encrypted PDF files within Data Collection/Form workflows, and also 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. In a future release of ClinSpark, support may be offered allowing customers to customize these limits.