- Patient Details:
Initials and other relevant identifier (hospital or out-patient department (OPD) record number etc.)*
Gender
Age or date of birth
Weight
Height - Suspected Drug(s):
- Generic name of the drug*
- Indication(s) for which suspect drug was prescribed or tested.
- Dosage form and strength.
- Daily dose and regimen (specify units – e.g., mg, ml, mg /kg).
- Route of administration.
- Starting date and time of day.
- Stopping date and time, or duration of treatment
- Other Treatment(s):
- Provide the same information for concomitant drugs (including non-prescription or Over the Counter OTC drugs) and non-drug therapies, as for the suspected drug(s).
- Details of Serious Adverse Event:
- Full description of the event including body site and severity, as well as the criterion (or criteria) for considering the report as serious. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the event*
- Start date (and time) of onset of event.
- Stop date (and time) or duration of event.
- Dechallenge and rechallenge information.
- Setting (e.g., hospital, out-patient clinic, home, nursing home).
- Outcome
- Information on recovery and any sequelae; results of specific tests or treatment that may have been conducted.
- For a fatal outcome, cause of death and a comment on its possible relationship to the suspected event; Any post-mortem findings.
- Other information: anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations etc.
- Details about the Investigator*
- Name and Address
- Telephone number Profession (specialty)
- Date of reporting the event to Central Licencing Authority:
- Date of reporting the event to ethics committee overseeing the site:
- Signature of the Investigator or Sponsor
- Note: Information marked * must be provided.
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