US 11,657,904 B2
Method and apparatus for adjusting event timestamp relating to clinical trial
Arttu Heikkilä, Vantaa (FI); Mika Jalkanen, Espoo (FI); and Mika Lankinen, Lepsämä (FI)
Assigned to CRF BOX OY, Helsinki (FI)
Filed on Jun. 20, 2017, as Appl. No. 15/627,639.
Claims priority of application No. 1611256 (GB), filed on Jun. 29, 2016.
Prior Publication US 2018/0004916 A1, Jan. 4, 2018
Int. Cl. G16H 10/20 (2018.01); G06F 16/23 (2019.01); G16H 10/65 (2018.01); G16H 40/67 (2018.01)
CPC G16H 10/20 (2018.01) [G06F 16/2358 (2019.01); G16H 10/65 (2018.01); G16H 40/67 (2018.01)] 16 Claims
OG exemplary drawing
1. A computer implemented method comprising:
receiving an event log corresponding to event entries of an electronic diary of a participant of a clinical trial, wherein the event log is generated in a client device, and the event log comprising at least two event entries, each of the at least two event entries associated with an event identifier and an event timestamp;
determining a block of event entries within the event log, the block comprising a first event entry and a second event entry at least one of whose event timestamps are verified being correct in view of corresponding service timestamps of a server apparatus, the server apparatus comprising a storage device for storing the event log, wherein the first and the second event entry are arranged chronologically;
maintaining trusted clock information at the server apparatus for providing service timestamps used for verification of event timestamps of the at least two event entries;
generating a tag to at least one event entry for indicating the automatic adjusting of the event timestamp;
approving the event entry as valid entry for trial data of the clinical trial in response to generation of the tag indicating the automatic adjusting of the event timestamp;
adjusting the event timestamp of at least one of the first and the second event entry based on the timestamp verified being correct;
generating a synchronization message for the client device in response to adjusting the event timestamp;
executing a synchronization when the client device and the server apparatus are connected to each other for data transfer;
modifying a local clock of the client device based on a time correction value in the synchronization message;
receiving participant data from the client device or a personal device;
maintaining the event log and the participant data generated by the electronic diary at the server apparatus for clinical trial processing, wherein the participant data being recorded by the personal device without user input.