Pharmacovigilance case intake is the hour when a report stops being an email and becomes a case. A PV case intake form is how a small drug-safety team captures that hour in one place. The form is not a safety database, and filling it in is not adverse event reporting to FDA or EMA. It is the record a qualified person needs before anyone can decide seriousness, expectedness, or whether a clock is running.
What intake is for
Sites, CROs, call centers, and medical monitors do not speak in E2B(R3) fields. They send a PDF, a three-line email, or a product quality complaint that happens to mention a patient. Intake is the translation step. Someone records the source wording, the dates, and the product, then a reviewer decides what the case is. Teams that skip this step retype the story later, usually after the weekend, and then argue about Day 0.
The drug safety inbox is where that delay actually happens. The intake form is the way out of the inbox. Full pharmacovigilance — submissions, signals, aggregate reports, a system of record — starts after intake. The difference is spelled out in AE intake versus full pharmacovigilance.
The four elements that make a case valid
ICH practice, used for both clinical and post-approval cases, treats an individual case as valid when four elements are present:
- Identifiable reporter. A person who can be contacted. A name and a role are enough to start. An anonymous tweet with no way back is not.
- Identifiable patient. Initials, a subject number, age and sex, or a chart reference. The patient does not have to be named in the intake file you store.
- Suspect product. The drug, biologic, or device under study or on the market. Dose and lot help. A missing lot does not erase an adverse event.
- Adverse event. What happened, in the reporter's words, with onset if you have it. A coding term can wait. The verbatim cannot.
If one element is missing, the case is a follow-up, not a discard. The intake form should show which element is missing and who was asked for it. That single habit prevents a serious report from sitting in a mailbox because the subject ID was in the attachment.
What else a useful intake form holds
Minimum criteria open the case. The next fields are what a reviewer needs for AE and SAE reporting and, when the criteria are met, SUSAR reporting.
- Dates: when the sponsor or designee first received the report, when the event started, and when the product was given. Receipt date is the one teams lose.
- Seriousness criteria, left blank until a qualified person marks them. Do not let a checkbox on a site form become the sponsor's decision without a look.
- Outcome, if known, and whether the event was still going on at the time of the report.
- The reference safety document used for expectedness: Investigator's Brochure or company core data sheet, with a version. The form can name the document. It should not pretend to be the document.
- Concomitant products and the medical history that would change causality.
- For a quality defect, lot or batch, and whether a patient was involved. That split is the subject of product quality complaint reporting.
Intake forms versus the safety database
Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record. They are a poor place to discover, on a Sunday, that a coordinator's email was a serious report. AE Connect is the intake step that integrates with them, and with any other safety database: read the source, draft the assessment, and integrate the reviewed case. The tables are on Argus, LifeSphere, and Vault Safety.
How the AE Connect intake works
The AE Connect workspace is a single intake, not a forty-field wizard and not a ten-language form pack. You paste the narrative or upload a PDF, Word file, text file, email, CSV, or image. Parsing runs in the browser. Only the extracted text is assessed. The draft covers seriousness, a suggested MedDRA preferred term and system organ class, WHO-UMC causality, expectedness, a reporting timeline, and a short narrative. You accept or override each field.
Expectedness in that draft is a prompt to check the current Investigator's Brochure or company core data sheet. The workspace does not store or author that document. The draft is not an E2B(R3) file and it is not sent to a gateway. Submission is a later job, described in E2B(R3) ICSR submissions.
A company email starts a 14-day sandbox trial. Annual subscriptions are Starter, Growth, and Scale. AE Connect can feed a safety database or be the safety database for the full ICSR and the E2B(R3) file.
Open a case in the workspace
Paste or upload a source at the AE Connect workspace. A company email starts a 14-day sandbox trial with unlimited cases. You accept or override every field. AE Connect can feed any safety database, including Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety, or it can be the safety database for the full ICSR and the E2B(R3) file.
FAQ
What is a PV case intake form?
A PV case intake form is the first structured record of a possible adverse event: who reported it, which patient it concerns, which product is suspected, and what happened. It is the front door of pharmacovigilance case processing. It is not the regulatory submission.
What is the minimum information for a valid individual case?
Four elements are widely treated as the minimum for a valid individual case safety report: an identifiable reporter, an identifiable patient, a suspect product, and an adverse event or reaction. A case can be opened for follow-up when one element is still thin. Your SOP should say who decides the case is valid and when the clock starts.
Does AE Connect replace the intake screens in Argus, LifeSphere, or Veeva?
No. If a safety database is the system of record, its screens stay the official entry. AE Connect turns an email, PDF, or pasted narrative into a reviewed draft. It does not write cases into Oracle Argus, ArisGlobal LifeSphere, or Veeva Vault Safety.
Can intake be an upload instead of a long form?
Yes in the AE Connect workspace. You paste text or upload a PDF, Word file, text file, email, CSV, or image. The file is parsed in the browser, and the assessment uses the extracted text. You still review the draft. An upload is not a finished case and it is not an ICSR submission.