format (available at ) that is widely accepted as the standard within the pharmaceutical industry. Information on the final description and evaluation of an adverse reaction report may not be available within the required time frames for reporting. For regulatory purposes, initial expedited reports should be submitted within the time limits and must contain the following minimum information: A suspected investigational medicinal product An identifiable subject (e.g. study subject code number) An adverse event assessed as serious and unexpected, and for which there is a reasonable suspected causal relationship An identifiable reporting source Where applicable, EudraCT number or in case of non EU trials the Sponsor's trial protocol code number A unique case identification, i.e. Sponsor's case identification number Where there is incomplete information at the time of initial reporting, all the appropriate information for an adequate analysis of causality should be actively sought. The Sponsor or delegate should report further relevant information after receipt as follow-up reports. Guidance on research adverse event forms The research protocol number requested on the form refers to the number used by the Trust to identify Trust research on the National research register and will be written on your Trust approval letter. Do not delay sending the form if this number is not available, provide the full title and version number instead. Document events in a clear way as far as possible. For example, the patient may say that they sick’. This can be interpreted in many ‘felt ways: either they felt nauseated or they may have felt unwell, or they may even have been vomiting.
format (available at ) that is widely accepted as the standard within the pharmaceutical industry. Information on the final description and evaluation of an adverse reaction report may not be available within the required time frames for reporting. For regulatory purposes, initial expedited reports should be submitted within the time limits and must contain the following minimum information: A suspected investigational medicinal product An identifiable subject (e.g. study subject code number) An adverse event assessed as serious and unexpected, and for which there is a reasonable suspected causal relationship An identifiable reporting source Where applicable, EudraCT number or in case of non EU trials the Sponsor's trial protocol code number A unique case identification, i.e. Sponsor's case identification number Where there is incomplete information at the time of initial reporting, all the appropriate information for an adequate analysis of causality should be actively sought. The Sponsor or delegate should report further relevant information after receipt as follow-up reports. Guidance on research adverse event forms The research protocol number requested on the form refers to the number used by the Trust to identify Trust research on the National research register and will be written on your Trust approval letter. Do not delay sending the form if this number is not available, provide the full title and version number instead. Document events in a clear way as far as possible. For example, the patient may say that they ‘felt sick’. This can be interpreted in many ways: either they felt nauseated or they may have felt unwell, or they may even have been vomiting.
SOP%2001%20-%20Pharmacovigilance_final%20v2.docx