QUALIFYING DATA AND ASSOCIATED METADATA DURING A DATA COLLECTION PROCESS
First Claim
1. A method implemented by a computing device for processing metadata associated with a clinical trial, the method comprising:
- receiving collected data from the clinical trial with embedded metadata;
extracting the embedded metadata;
accessing a database for determining characteristics of the embedded metadata;
accessing protocol rules, wherein the protocol rules comprise a set of clinical trial requirements and procedures;
ensuring compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules; and
reporting the compliance or non-compliance of the collected data.
1 Assignment
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Accused Products
Abstract
Systems and methods for processing metadata associated with a clinical trial are described. In one aspect, a computing device receives collected data with embedded metadata. The device extracts the embedded metadata, and accesses a database to determine characteristics of the embedded metadata. The device then accesses protocol rules where the protocol rules are a set of data collection requirements and procedures for a given clinical trial. The device ensures compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules. The device then reports the compliance or non-compliance of the collected data.
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Citations
20 Claims
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1. A method implemented by a computing device for processing metadata associated with a clinical trial, the method comprising:
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receiving collected data from the clinical trial with embedded metadata; extracting the embedded metadata; accessing a database for determining characteristics of the embedded metadata; accessing protocol rules, wherein the protocol rules comprise a set of clinical trial requirements and procedures; ensuring compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules; and reporting the compliance or non-compliance of the collected data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A data processing system for processing metadata associated with a clinical trial, the data processing system comprising:
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a data processing device comprising a processor and a memory; and wherein the data processing device receives data from a client computer, wherein the data comprises clinical data and administrative data, wherein the administrative data is embedded within the clinical data as metadata, extracting the administrative data, determining compliance of the administrative data with a clinical trial data acquisition protocol, and reporting the compliance or non-compliance of the administrative data. - View Dependent Claims (15, 16, 17)
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18. A computer readable data storage medium comprising computer-program instructions executable by a process, the computer-program instructions, when executed by the processor, for implementing steps comprising:
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accepting clinical trial data; accepting procedural information regarding the acquisition of the clinical trial data; embedding the procedural information into the clinical trial data in metadata; sending the combined procedural information and clinical trial data as a single piece of data to a database for storage; and wherein the metadata is encoded to be accessible to systems receiving the combined procedural information and clinical trial data. - View Dependent Claims (19, 20)
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Specification