Serious Adverse Event Report Form - Fill-in clinical SAE reporting details

Sep 12, 2026

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Serious Adverse Event Report Form designed to capture complete clinical safety information for a participant’s serious adverse event within a study. It collects reporting type and identifiers, site details, participant demographics, event name and detailed description, SAE start/stop dates and awareness timing, and the specific seriousness criteria. It also records relevant medical history, laboratory results, study drug exposure and action taken, concomitant and non-study medications, and the event outcome including mortality and post-mortem information, plus follow-up status and reporter sign-off.

LanguageEnglish

CategoryForms

FormatPDF

Pages5

Reading Time2 min

AccessFree to download

Section 1: Reporting metadata

Report type and form/SAE numbers

Site information

Section 2: Participant and event details

Participant identifiers and demographics

Adverse event name and description

SAE start/stop and awareness dates/times

Seriousness classification criteria

Section 3: Clinical context and results

Relevant medical history

Laboratory results relevant to the SAE

Study drug details and actions taken

Concomitant and non-study medications

Section 4: Outcome and follow-up

Outcome of event and death details

Further information and follow-up reporting

Reporter signature and completion date

27/02/2024 , 11:42 Serious Adverse Event Report Form Serious Adverse Event Report Form | Serious Adverse Event | | | | | --- | --- | --- | --- | | 1. Report type | * | *
SAE number
If this CRF relates to the patient 's ﬁrst SAE, enter 1. If the patient has had more than one SAE, please record the SAE number that this applies to | *
Form number (for this SAE)
If this is the initial report, enter 1. If this is a follow-up form, please record the number of CRFs you have attempted to complete for this SAE, including this one | | If this is the ﬁrst time the SAE has been reported, please select"Initial report ". If you are submitting new, updated or corrected information for a previously reported SAE, please select "Follow-up information ".
Initial report Follow-up information | | | | | » 2. Site | | | | | Site name | | Site name (if not in list) | | | » 2. Site | | | | | Site name | | Site name (if not in list) | | | » 3. Participant details | | | | | Study number | | | | | Participant's initials | | | | | *
Date of birth
yyyy-mm-dd | | | | | Patient's year of birth | | | | | Sex
Male Female | | | | [https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview](https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview) 1/5 27/02/2024 , 11:42 Serious Adverse Event Report Form | 4.1 Adverse event name
Description of SAE in a few words at most e.g. Pneumonia, Seizure, Gastrointestinal bleed | | | | --- | --- | --- | | 4.2 Adverse Event description
Please record: i) diagnosis if known, ii) an account of the event (including signs and symptoms if diagnosis not known), iii) any interventions given to manage the event (including dates for these), and iv) if the event was fatal, the cause of death if known | | | | 5. Start date of SAE
yyyy-mm-dd | Start time of SAE
(hh:mm [24 hr]) | | | 6. Stop date of SAE
yyyy-mm-dd | Stop time of SAE
(hh:mm [24 hr]) | or Ongoing?
Yes | | 7. Date site became aware of SAE
yyyy-mm-dd | Time site became aware of SAE
(hh:mm [24 hr]) | | | 8. Reason this event is classed as serious
If there is more than one reason which applies then choose the more/most signiﬁcant one and document other reason(s) in the AE description
Fatal Life threatening Requiring/prolonging hospitalisation Congenital anomaly/birth defect Signiﬁcant disability/incapacity Other important medical event
Event does not fulﬁl criteria for being serious | | | | The RECOVERY protocol does not require non-serious events to be recorded. Please check your answer. | | | | | | | | 9. Relevant medical history
Provide a full description of any medical history which could be relevant to this SAE and which may need to be considered by the individual reviewing the event (including co-existing medical conditions, allergies or similar experiences) | | | | 10. Laboratory results relevant to the SAE
Please give details of relevant results, dates and reference ranges in the space below or send a printout with these details highlighted and patient identiﬁable information obscured | | | | If this event is believed to be related to more than one study treatment, please press the + button to add a new row. | | | [https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview](https://npeu.openclinica.io/OpenClinica/EnketoFormServlet?formLayoutId=101&studyEventId=0&eventCrfId=0&originatingPage=&mode=preview) 2/5 27/02/2024 , 11:42 Serious Adverse Event Report Form 11. Specify the study drug details below (for the drug this SAE is believed to be related to) Study drug name Dose Frequency Route Date started yyyy-mm-dd If discontinued, date stopped yyyy-mm-dd Did the event resolve after stopping

FAQs

What information is required to identify the SAE report and determine whether it is initial or follow-up?

The form requests the SAE number, the form number for the SAE, and selection of Initial report or Follow-up information depending on whether the SAE was previously reported.

How should the seriousness of the event be classified on the form?

Select the most/most significant reason that makes the event serious (e.g., fatal, life threatening, requiring hospitalization, disability, or other important medical event) and document any additional applicable reasons in the event description.

What fields are used to document study drug exposure and management actions related to the SAE?

The form collects study drug name, dose, frequency, route, dates started and (if applicable) stopped, whether the event resolved after stopping, whether it reappeared after reintroduction, and action(s) taken such as discontinued temporarily, dose reduced, or discontinued.

Sep 12, 2026

Upload by Sage