Data & Analysis

Source data is "All information in original records and certified copies of original records or clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.” (Section 1.51, Notes for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA Comments)

Therefore, source documents are a type of “essential documents” which contain source data (Essential Documents as defined in Research Participants & Trial Conduct – Management of Essential Documents). They are the location where each datapoint is first recorded. 

Examples of documents that contain source data include:  

·        medical records [now Electronic Medical Records (EMR)] 

·        recorded data from automated instruments (e.g. blood pressure measurements or ECGs and reports). 

·        participant - or researcher-completed questionnaires or rating scales; diaries 

·        videos or photographs 

·        pharmacy dispensing and other records; 

·        laboratory results; 

·        imaging scans and reports 

Because you and your study team are the ones collecting data as part of this study, you will be responsible for your source document management as well. This means that the lead Investigator should maintain adequate and accurate source documents and trial records that include all pertinent observations on each trial participant and maintain a record of the location(s) of their respective essential documents, including source documents. 

This topic is covered in some detail in GCP courses. For more information on CRFs and Source Documents: 

·        MCTC004 Guidance | Data collection for research: Source documents and Case Report Form

·        MCTC015 Template | Source Document Plan

All research, including clinical trials, involves the collection and management of data. Since your study has an external sponsor, it is likely that you and your study team will do most of the collection of data, and your external sponsor will do most of the management of data.  

As part of this, your external sponsor will provide you with the tools you need to collect and record the data required as part of your protocol. These will most likely include:  

·        Case Report Forms (CRFs, used to capture each participant’s study data across the life of the study) 

·        Standardized Questionnaires and Patient Reported Outcome tools (PROs, where participants can self-report their own study data in response to stimulus questions)  

·        Electronic Data Capture systems and databases (EDCs, commonly used to host CRFs, Questionnaires and PROs, etc).  

For more in-depth information on this topic: Policies and Templates Research Data Management Policy.

MCRI implemented the Change Advisory Body (CAB) to ensure that appropriate governance and information security measures are considered when dealing with MCRI data. Most research projects have to go through the CAB Approval Process, regardless of whether they are externally sponsored or not. The full list of qualifying criteria, and more information, can be found at Change Advisory Body (CAB): Data Transfer.

The MCRI Data Office can help you with your responsibilities in these areas through DataConnect.

For more in-depth training on this topic, enrol in an A-CTEC Data Management Course.