This means for select study visits, there is no difference between a participant who is physically present versus a participant who is virtually present. The FDA has established, when a participant is virtually present at the clinical trial site the source data remains unchanged. In conclusion, existing protocols (not just DCT focused) can utilize MedVector to enable participation from alternate locations. For these data elements, the eCRF is the source.” This direct entry of data can eliminate errors by not using a paper transcription step before entry into the eCRF. “ Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered directly into the eCRF by an authorized data originator. To get a free trial, you simply have to apply for it on the free trial page. This is to allow intending users to get a complete feel of the products before making a commitment. offers a free trial version of their software for 30 days.

When basic measurements are taken by a local nurse (e.g., blood pressure, weight, temperature, pill count, etc.) and entered directly into the EDC by an authorized originator, the source is the clinical trial site and not the participant location.įDA Guidance for Industry (September 2013)Įlectronic Source Data in Clinical Investigations As most software makers do, Vectorworks Inc. Use the PitchBook Platform to explore the full. When engaging a participant at an alternate location using telemedicine, there are sometimes questions regarding the source data location. Information on acquisition, funding, investors, and executives for Vectorworks.

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