April 13, 2022
Case Transmission Verification: Cases received from Business Partners, Health Authorities or Service Providers typically need to be acknowledged or verified to confirm a successful transmission. In 2020:45% of respondents were applying at least some automation.55% of respondents reported no automation of this ICSR process step.In 2021:61% of respondents were applying at least some automation.39% of respondents…
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February 14, 2020
Archive Source Data: Archiving source data or documents in local language at the point of intake, if required, for retrieval and review. In 2020:65% of respondents were applying at least some level of automation.35% of respondents reported no automation of this ICSR process step.In 2021:78% of respondents were applying at least some automation.22% of respondents…
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February 14, 2020
Case Translation: Depending on the company intake model, language translation upon intake may be required. This is predominantly from non-English to English and allows full case processing in a central location. In 2020:65% of respondents were applying at least some level of automation.35% of respondents reported no automation of this ICSR process step.In 2021:83% of…
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January 16, 2020
Prioritization/Triage: Recognition and review of key characteristics to route the case to assign an appropriate workflow/timeline. Prioritization is typically based on factors such as death or life-threatening events, case seriousness, country-specific reporting timelines, association (relatedness), and/or expectedness. Once cases have been prioritized, they are assigned to an appropriate workflow/person. In 2020:60% of respondents were applying…
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January 16, 2020
Local Structuring: During local intake, country pharmacovigilance teams convert unstructured data into local intake forms (or other paper or electronic formats) for local, regional, or global case processing centers. In 2020:45% of respondents were applying at least some level of automation.55% of respondents reported no automation of this ICSR process step.In 2021:56% of respondents were…
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January 16, 2020
Local Tracking: Local tracking of received adverse events allows the local office/affiliate or regional centers to perform proper follow-up activities. In 2020:35% of respondents were applying at least some level of automation.65% of respondents reported no automation of this ICSR process step.In 2021:50% of respondents were applying at least some automation.50% of respondents reported no automation of…
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January 16, 2020
Prepare and Send to Global Site: Complete the intake process to communicate the adverse event information to the site for processing. This can involve data entry to an online form, uploading of source documents, and any required translations. Prepared cases can then be sent to case regional or global processing sites as per the structural…
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January 16, 2020
Case Validation: Checking for minimum criteria to ensure that the case is valid and/or to be sent for processing (e.g. patient, reporter, suspect product and adverse event). Once the new record or case is available in the safety data base, additional checks are performed. These include review for valid criteria and confirmation of whether the…
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January 16, 2020
Alert Case of Interest: Notifications for some cases with specified critical features might be required (e.g., alert stakeholders in clinical, safety and management functions as needed; notifications to medical review, risk management, unblinding). In 2020:40% of respondents were applying at least some level of automation.60% of respondents reported no automation of this ICSR process step.In…
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January 16, 2020
Data Acquisition: The process for receipt of adverse event reports to the initial PV contact in the Company. The local intake process for all case types typically starts with acknowledgment of receipt, which is required in some instances (e.g., cases from business partners or clinical trials). In 2020:70% of respondents were applying at least some…
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