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Essential Reading Lists

Data Manager resources

This reading list draws together resources that we think will be helpful if you are working as a data manager on a trial. It is not an exhaustive list but rather a recommended package of resources.

Webinar - How to be a good Data Manager	Video: How to be a good Data manager
Data cleaning and quality SOP	SOP: To outline the procedures related to ensuring queries are raised, managed and resolved appropriately To detail methods of data cleaning and monitoring throughout the trial
Data management plan template	This document is associated with the Data management documentation and training SOP. The purpose of this SOP is: To outline the documents which are needed to facilitate data management in a study To outline the procedures related to the training required to conduct data management activities.
Data receipt and entry SOP	The purpose of this SOP is to outline the procedures related to the receipt and entry of study data.
Database development	The purpose of this SOP (Standard Operating Procedure) is: To provide a procedure for developing a database system in compliance with the principles of ICH GCP and any other regulatory requirements relevant to the development To provide a procedure which will be able to demonstrate through documented evidence that the database system is fit for its intended purpose and able to consistently maintain this state. To identify the documents which must be produced as part of a database system development. To define the roles involved in developing a database system and their respective responsibilities.
Management of personal data	The personal data which is collected during the running of studies at MRC CTU is processed in order to answer the study questions.
Data management documentation and training	The purpose of this SOP is: To outline the documents which are needed to facilitate data management in a study To outline the procedures related to the training required to conduct data management activities. This includes: - Staff working within the unit - Site staff providing data either by eDC, rDC or completion of paper CRFs received at the CTU To outline the methods which will be used to check that training has been conducted appropriately.
Missing data in clinical trials: how to reduce it, handle it and report it	Missing data in clinical trials: how to reduce it, handle it and report it
Team science - the importance of the team in clinical trials	Team science - The importance of the team in clinical trials
Data manager handover schedule	This document is associated with the Data management documentation and training SOP. The purpose of this SOP is: To outline the documents which are needed to facilitate data management in a study To outline the procedures related to the training required to conduct data management activities.
Database lock SOP	The purpose of this SOP (Standard Operating Procedure) is: To outline the procedures for locking databases containing trial data at MRC CTU: to meet regulatory requirements to provide evidence of data quality of data used in final or published analyses to provide traceability of data used in final or published analyses To define the MRC CTU roles and responsibilities involved in the database lock procedure To highlight the use of database lock procedures in platform trials To describe the process of providing a copy of site data to sites in eDC trials after final database lock

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