A clinical trial is intended to find answers to the research question by means of generating data to prove or disprove a hypothesis. Clinical Data Management (CDM) is a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.
The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drives decision-making on product development in the pharmaceutical industry. Thus, it is imperative that the data is accurate and organized for the successful development of new medical treatments.
The process of gathering information for use in the study is known as ‘data collection’. Data in clinical research is collected in different ways. The data is usually raw and includes information such as participants’ demographics which is collected by the clinical trials administrator/receptionist. And, an Informed consent form which is discussed and explained by Nurses/Doctors and is signed by the participant, as well as physical exams and vitals conducted by nurses. In addition, the raw data collected also includes all other relevant information collected after screening participants.
After the data from participants is collected, it is then stored in the source document, in accordance with the study protocol and Electronic Case Report Form (ECRF) guidelines. Source documentation assists with reconstructing a trial as it happened. Furthermore, if the documentation is done properly during a study, it can provide an audit trail which will be helpful during auditing and inspections.
The data collection and protection systems used in clinical research anonymise participants through random identification numbers which are used by participants throughout a clinical trial.
Once the data is collected, CRISMO uses an internal system known as ‘Real-Time’ to store the data. In addition, the sponsor also has specific systems that are used to store the data collected by CRISMO. These systems show when the participant was screened and enrolled in the study. Furthermore, they assess whether the data collected responds to the clinical trial question and answers the primary, secondary, and exploratory objectives of the study.
Data systems are secured by Usernames and passwords to protect the integrity of the data and track who entered and or manipulated data at any time.
Hard copy files are stored and locked, and only designated personnel has access to those rooms. When the study is concluded the files are stored under strict conditions internally onsite or externally at a designated archive company for a period of 15 years.
The sponsor then monitors the data every four to six weeks, to ensure that the data is clean, accurate, and reliable. The South African Health Product Regulatory Authority (SAHPRA) inspects the site to ensure that it has adhered to the GCP guidelines, study protocol and that the safety of the participant is not compromised in any way.
It is essential for the site to adhere to all relevant and mandatory regulations before any data is collected. A key element of data management is the development and implementation of guidelines and standard operating procedures (SOPs) that define safe and efficient ways of collecting and managing data.