The sponsor of a clinical trial or study is responsible for ensuring the quality of data and safety of participants. Quality assurance and quality control methods are implemented to achieve this. Quality assurance systems ensure that the conduct of the trial is in accordance to the protocol, Good Clinical Practice (GCP) guidelines and the applicable regulatory guidelines. Additionally, they also safeguard the integrity of the data generated from the trial.

One of the prerequisites of a quality assurance system is documented Standard Operating Procedures (SOPs) and written agreements. Ideally, the institute delegated by the sponsor to coordinate the trial would develop a set of SOPs relating to all stages of a clinical trial.  If trials are run through clinical trials units, then the latter will have template SOPs for a number of processes that are then used to produce customised trial specific working practices/working instructions.

Quality assurance is implemented through quality control and auditing. Operational techniques and activities that are undertaken within the quality assurance system are referred to as quality control activities. Quality control should be applied to each stage of data handling. The main objective of quality control is to ensure data reliability and that the data has been processed correctly. This will further avoid exposure of trial participants to unnecessary risks, and avoid false conclusions to be drawn from the data. Quality control is applicable to the teams involved in planning, conducting, monitoring, evaluating, data handling and reporting.

Some examples of quality control are:

• Specifications and instructions for anticipated protocol deviations
• Training of the research team members (on an ongoing basis) on the protocol, applicable regulatory requirements and GCP guidelines.
• Clear allocation of responsibilities and duties within the team
• Development of plans for monitoring, study feasibility, safety reporting, etc.

From a regulatory perspective, clinical trial sites, sponsor or Contract Research Organisation’s facilities may be inspected by the Central Drugs Standard Control Organization (CDSCO). CDSCO may conduct an inspection to verify compliance to GCP guidelines, verify credibility and integrity of clinical trial data generated, and compliance to applicable regulatory provisions. These inspections may be conducted before, during or after a clinical trial is completed. The inspection may be a part of routine surveillance or due to a specific reason(s). For example, data irregularities or vulnerability of trial participants may trigger an inspection. It is important that the sponsor is aware that an inspection may be conducted, and ensures that the quality of the trial and safety of participants is maintained throughout the trial.

The next sub-sections of this routemap provide information on some of the documents that should be prepared for a trial, to ensure its quality:

• Sponsor Specific Processes and Documents
• Pharmacovigilance Plan
• Monitoring Plan
• Safety Management Plan
• Randomisation System Development and User Acceptance Testing
• Database Design, Development and User Acceptance Testing
• Statistical Analysis Plan
• Data Management Plan

References and further reading

• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
• ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9^th November 2016, available online (last accessed on 26.02.2019).
• Further reading for clinical trial inspection: Guidance on Clinical Trial Inspection, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2010, available online (last accessed 0n 26.02.2019).