Introduction for the Pharmacovigilance standard documents

This excel template allows you to track all reportable safety events such as serious adverse events, adverse events of special interest, overdoses, pregnancies. It summarises which reportable events occurs in which patient, when the reportable event was sent to the various recipients (PV unit, Ethics Committees, etc.) and allows you to track whether the site still needs to follow-up on that event or whether it is closed. We recommend the tracker is customised to your needs.

Target user: All

Summary with examples illustrating adverse events of special interest situations reportable in the study. If your project includes the reporting of adverse events of special interest with specific definitions, it can be helpful to have a 1-2 pager summarizing how to identify these adverse events of special interest. This was a request from the site doctors.

Target user: TB doctors

Study site procedure describing how to collect and report safety data including serious adverse events, adverse events of special interest, pregnancies, overdoses and also periodic reports and safety signals. Reporting to the Sponsor pharmacovigilance unit, Ethics Committees, Data and Safety Monitoring Boards, National Regulatory Agencies is described.

Target user: Study coordinators, TB doctors

Sponsor procedure describing how to reconcile a clinical trial database with a pharmacovigilance database. If you use a clinical trial database and a pharmacovigilance database in your study, it is recommended to regularly reconcile data on serious adverse events and adverse events of special interest (reconcile means compare the information such as SAE term, onset date, outcome...). This ensures data integrity and that no such important event is missed (e.g. outcome fatal in one database and resolved in the other database could mean you missed a death/SAE).

SAE report form completion guidelines. This guideline explains how to fill the form (PV-TB-F01).

Target user: TB doctors, Site monitors

Pregnancy report form completion guidelines. This guideline explains how to fill the form (PV-TB-F02).

Target user: TB doctors, Site monitors

Severity grading scale describing how to evaluate adverse events intensity/severity (grade 1-2-3-4). It provides harmonised definitions of severity grade 1-2-3-4 for specific conditions as well as recommendation on general grading. It is recommended to use the scale or define a scale when you collect and assess adverse events in your study. This way you ensure data is as harmonised as possible, i.e., a grade 1 anaemia at site A is going to be the same as a grade 1 anaemia at site B. Please note we also have an FAQ document (PV-TB-D21) to further assist doctors with severity grading.

An annex to the safety data reconciliation procedure that summarizes. In link with the procedure on safety data reconciliation, in our project we chose to have the safety data reconciliation plan separated from the procedure to ease changes in dates/planning/scope/mapping information. You can choose to integrate all in a procedure if more convenient for your project.

Target user: Sponsor, Study coordinator

Severity grading scale "frequently asked questions" document. The Pharmacovigilance unit has gathered the frequently asked questions from doctors on the severity grading and the use of severity grading scale (PV-TB-D12) and gathered answers into this document to be used in conjunction with the severity grading scale. If you have more questions please feel free to contact us as indicated in the FAQ.

Target user: All

Recapitulation of all local (country/site) safety reporting obligations. This document gathers all local safety reporting requirements for the study from the various local Ethics Committees and local regulatory authorities. It is very helpful in an international multi-site study. If you plan a study with 1 site, it is probably not necessary to use this template as you can describe all the details of the process in the SOP (PV-001-CT) directly.

Target user: Sponsor, Study coordinator

Recapitulation of all safety monitoring processes for the study. In a complex study with several different safety monitoring processes, we recommend a safety monitoring plan summarizes all activities in a comprehensive manner. This document can be used to answer inquiries on safety monitoring in the study from Ethics Committees and Regulatory Agencies.

Target user: Sponsor, Study coordinator

This form allows you to capture relevant information on Serious Adverse Events occurring in study participants. We also used the same form for Adverse Events of Special Interest and Overdoses in the study (see PV-TB-D01 for details on how to capture). This form is filled by the site doctor and can be used for reporting to the Pharmacovigilance unit but also reporting to Ethics Committees and National Regulatory Agencies if accepted. 

Target user: TB doctors

This form allows you to capture relevant information on participant or participant's partner who became pregnant during the study. Collection of partner's pregnancy (e.g., the wife of a male participant becomes pregnant during the husband study participation) is up for you to decide if applicable to your project (e.g., suspicion of male reproductive toxicity).

Target user: TB doctors

Sponsor procedure describing how to code adverse events using the Medical Dictionary for Regulatory Activities (MedDRA). This procedure explains the strategy to code adverse event using the MedDRA dictionary. It is important to consider how you are going to harmonise adverse event terms in your study so you can report meaningful results (e.g., liver enz increase, liver enzyme increased, elevated liver enzyme = these are all the same term spelled out slightly differently).

Internal pharmacovigilance unit data collection, processing and reporting procedure.

This procedure details the organisation of safety (pharmacovigilance) data collection, processing and reporting. It is useful if you set up your own pharmacovigilance unit.

Target user: Sponsor pharmacovigilance officer

Internal pharmacovigilance unit procedure detailing safety (pharmacovigilance) database administration.

If you use a safety/pharmacovigilance database, it is recommended to detail in a procedure how the database is administered. This simple procedure can be used as a template.

Target user: Sponsor pharmacovigilance officer

Internal pharmacovigilance unit procedure detailing the data entry conventions in the safety (pharmacovigilance) database administration. If you use a safety/pharmacovigilance database, it is recommended to ensure data consistency to detail in a procedure how the data are entered in the database (which data go in which database fields and rules on how to capture). This simple procedure can be used as a template but please note the non-ICH database fields can be different.

Internal pharmacovigilance unit procedure detailing how compliance with pharmacovigilance processes is monitored and documented.

If you don't use a pharmacovigilance unit/department at Sponsor level, you can use the same process as in SM-005-CT. If you have a pharmacovigilance unit, you will need a dedicated compliance process that can be the same as we used in this SOP or similar to the study deviation process.

Target user: Sponsor pharmacovigilance officer

Internal pharmacovigilance unit procedure detailing how safety signals are detected, assessed, managed and reported.

This procedure can be used as a template to define your process for safety signal management and communication.

Target user: Sponsor pharmacovigilance officer

Internal pharmacovigilance unit procedure detailing how periodic safety reports are prepared, reviewed and submitted.

This procedure can be used as a template to define your process to gather data, write, review and submit periodic safety reports such as annual safety reports or 6-monthly safety reports.

Target user: Sponsor pharmacovigilance officer

Target user: Sponsor pharmacovigilance officer

We invite you to browse these other useful Toolkit pages: 

• Toolkit presentation
• Medical
• Pharmacy
• Observational study