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PDF import

With the PDF Import functionality, you can import safety data from the unstructured source documents, such as scanned SAE forms in the PDF format. The files can be uploaded manually or you can configure the email intake to pull the files automatically from the predefined mailbox and land them to PV for further processing. Based on the preconfigured template, the system is able to analyze and transcribe the file to retrieve the data and create an ICSR in PV.

Important

If you want to use PDF autotranscription, you need to provide a template to EDETEK administrator for the system to be configured to recognize your similar PDF uploads and properly interpret their contents.

This functionality saves time on manual data entry efforts and facilitates batch uploads. It offers the capability to upload multiple files simultaneously and process them, dividing them into multiple safety reports. Additionally, you can upload a bundle of files, select the primary one as the source of safety data, and attach the remaining files as source documents to your case. You can also configure the email intake to pull the files automatically from the predefined mailbox and land them to PV for further processing.

All the records for uploaded or retrieved from emails PDFs—the ones used to create ICSRs, rejected, or not yet processed—can be found in PDF Import List. The details available are interpreted in the following table.

PDF import list
Figure 1. PDF import list

Tip

The records on the list are based on the study access permission granted to you via ADMIN.

Column

Details

Case Number

Represents the unique identifier assigned by the system to the ICSR created or updated based on the data retrieved from the uploaded PDF. This value becomes available after a successful review and creation of an initial or follow-up report or upon an update of the existing ICSR with retrieved data.

This value is also an active link that you can select to open the ICSR in the new browser page.

Case Version

Represents the version of the case created based on the data retrieved from the uploaded PDF.

For instance, if the initial case is created, the version is 001, if the first follow-up is made to the initial version, the version is 002, the second follow-up is 003, and so on.

Case Status

Represents the current status of the case created based on the data retrieved from the uploaded PDF.

ID

Represents the unique identifier assigned by the system to the PDF file or a batch of files simultaneously uploaded to the system. This ID helps track the original import record even if it is split into multiple file groups that result in different ICSRs.

Status

Represents the current status of the PDF or its extracted data processing that can be one of the following:

  • Unprocessed: the file is uploaded but not yet processed by the user, so the data extraction is not initiated.

  • In Progress: the file is processed by the user, and the data extraction is initiated.

  • Process Failed: the file is processed by the system and the data extraction failed. You can troubleshoot the failure and reinitiate the PDF processing.

  • In Review: the file is successfully processed by the system and the data is extracted and ready for review.

  • Initial Report: the initial version of the ICSR is created in PV based on the safety data extracted from the uploaded file.

  • Update Report: the existing ICSR case in PV is updated with new data extracted from the uploaded file.

  • Follow-up Report: the follow-up version of the existing ICSR is created in PV based on the safety data extracted from the uploaded file.

  • Reject Import: the data extracted from the uploaded file was reviewed and rejected as redundant for further import in PV.

Comment

Represents the comment entered by the user when accepting the safety data to create an ICSR or rejecting the data import.

Source

Represents the origin of the file for data import as follows:

  • User uploaded: the file is manually uploaded by the system user.

  • Email intake: the file is automatically retrieved by the system from the preconfigured mailbox according to the email intake configuration.

Case Language

Represents the language of the ICSR management.

Assigned To

Represents the name of the user to whom the ICSR is assigned for review in PV.

Seriousness

Represents the level of the seriousness of extracted ICSR as the concatenated value when any event meets the criteria such as:

  • F: the event results in death.

  • LT: the event is life-threatening.

  • H: the event has caused or resulted in a prolonged patient hospitalisation.

  • DIS: the event is disabling or incapacitating for a patient.

  • CON: the event is a congenital anomaly or a birth defect in a patient.

  • IME: the event is an important medical event.

Case Country

Represents the country where the first AE occurred at the time of the initial case processing.

Case Receipt Date

Represents the latest date when the safety data is received.

Type of Report

Represents how the report originated, for instance, Report from Study or Spontaneous Report.

Suspect Products

Represents the concatenated value of all suspect products divided by semicolon.

Events

Represents the concatenated value of all reported events names divided by semicolon.

Patient Name or initials

Represents the patient's name or initials. The value can be masked (MSK) for blinding.

Study Name

Represents the study for which the case is reported.

Subject ID

Represents the unique identifier assigned to the subject during the course of the study.

Reporter's Name

Represents the name of the individual who reported the case.

Reporter’s Qualification

Represents the occupation of the individual who reported the case.

Reporter's Country

Represents the country of origin of the individual who reported the case.

Creator

Represents the name of the user who uploaded the file for processing.

Create Time

Represents the exact date, time, and time zone indicator of when the file is uploaded to PV.

Modified By

Represents the name of the user who performed the latest amendment to the file or extracted safety data.

Modified Time

Represents the exact date, time, and time zone indicator of when the latest amendment is made to the file or extracted safety data.

In the following sections, you can learn more about available operations for PDF import:

In this section:

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.