> For the complete documentation index, see [llms.txt](https://support.who-umc.org/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://support.who-umc.org/vigiflow-ereporting-for-industry/manual-data-entry/create-a-new-report.md).

# Create a new report

1. Go to **Data Entry** → **Create new report**.
2. Complete the eight sections of the report: *Administrative*, *Patient*, *Drugs*, *Reactions*, *Drug‑Reaction*, *Other*, *Assessments*, *Case summaries*.

{% hint style="info" %}
Fields must be completed according to national guidelines, company guidelines, and [ICH E2B guidelines](https://ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files).
{% endhint %}

 

### Setting the Worldwide unique ID (WWUID) and Safety report unique identifier (SRUID) <a href="#toc234917167" id="toc234917167"></a>

For manual data entry:

* The WWUID consists of: **Country code** (2‑letter ISO code) + **MAH short name** + **Unique report number** (**sequential number starting at 00001**).
* Users must enter the sequential part manually.
* The SRUID usually follows the same structure.
* Both identifiers remain the same across follow‑ups.

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### Completing the Report information page

While national guidelines should be followed, some fields have specific technical implications:

* **Date report was first received** (C.1.4): Date received from the primary source. Does not change for follow-ups.
* **Date of most recent information** (C.1.5): Updated each time follow-up information is received.
* **Does this case fulfil the local criteria for an expedited report?** Definition based on local regulatory requirements
* **SRUID** and **WWUID**: Follow structure → **Country code-MAH short name-Unique report number**.

&#x20;

### Mandatory fields and validation

* Empty mandatory fields are highlighted in **red** when attempting to **Submit**.
* Provide the missing value or use a *Null Flavour* code where appropriate.
* A valid initial report must meet these minimum criteria: identifiable reporter, identifiable patient, at least one suspected drug, and at least one adverse effect.
* The platform prevents submission until requirements are met.

{% hint style="info" %}
What are *null flavours*? *Null flavours* are standardised codes used to indicate why a data value is missing. They indicate whether the information is unknown, unavailable, or not applicable.
{% endhint %}

### Uploading additional documents

* Under “Additional documents”, you can upload supporting material.
* Describe the content of the file.
* Upload the file.&#x20;
  * Supported formats: pdf, jpeg, jpg, txt, rtf, tif, html, htm, doc, docx, xls, xlsx, dcm, and png.
  * Maximum size: 2 MB per file.
* Name files clearly; files are stored with the report but are not searchable.
* Click **Add additional document** to upload more files.

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---

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