Study-specific procedures and plans to facilitate the management of the research and can also be used in the event of an audit to justify the approaches taken.  

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Study Operations

Adverse events

Investigators in the Harvard Medical Practice Study define an 'adverse event' as "an injury that was caused by medical management (rather than the underlying disease) and that prolonged the hospitalization, produced a disability at the time of discharge, or both.

Serious Adverse Event (SAE) is defined as: An untoward occurrence that results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect. There are slight differences in definition for IMPs and non IMPs; Clinical Trial Regulations should be referred to for

SAE reporting checklist

Safety assessment and reporting

Serious adverse events form template

Serious adverse events log

Adverse events record template

Monitoring - Agreement for local independence


The type of monitoring may differ greatly between studies. A  plan will help establish the overall framework for the oversight and monitoring of a study. When formulating a plan the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements. 

Protocol violation log

REDe Quality Management Toolkit 2017

REDe Data Quality & Introducing Reciprocal Monitoring

Curriculum for monitoring training

Monitoring - visit log

Monitoring activities template

Monitoring checklist 
Protocol deviation log

Modular courses (TGHN e-Learning):

INTERGROWTH-21st course on maternal, fetal and newborn growth monitoring (available in: EspañolPortuguês)



The Participant Information Sheet and Consent Form are key documents and a major consideration during ethical review

Audio recording informed consent checklist

Subject informed consent log template

Informed consent template for sample only studies

Audiovisual recording of informed consent SOP 

Informed Consent Template Sample Only in Household community

Tools to help you conduct  your research. 

Study-specific procedures and plans to facilitate the management of the research and can also be used in the event of an audit to justify the approaches taken.



 Further resources

Through this facility research sites can register and let would-be collaborators and sponsors know about them, their previous experience and what type of research they would like to take part in. In turn, research groups wishing to find other sites to collaborate with can post their research plans and explain what they are looking for in terms of disease prevalence perhaps, or was facilities a research site has. 
These free, certificated and recognised courses are provided to give a general introduction to many of the key steps involved in setting up a study they include short topics such as Good Clinical PracticeGood Laboratory Practice and longer modular courses and cover many of the required steps such as setting the question, data management and community engagement.


The Process Map is a cross-cutting tool that guides the process of setting up a study and provides links to explanations about each component step and any tools, templates and training that exist on each step.


Main resources:

Study design & planning

Ethics & Regulatory

Study Procedures

Data Collection, Management & Anaylsis

Study Operations


Further resources: