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Ready for the new GCP ICH E6 (R2) addendum?
On the 23rd of July 2015, the EMA's Committee for Human Medicinal Products released the Guideline for Good Clinical Practice E6(R2) for consultation. On the 14th of June 2017, it will come into effect and influence everyone involved in the clinical research process. What does it mean to pharma and biotech companies, sponsors, CROs, research institutes and third-party organizations?
As a reaction to the advancements in technology over the last twenty years, the latest GCP draft represents the biggest revision of the GCP ICH guidelines since 1996. With its main objective to harmonize existing guidance from the FDA, the EMA and others, it is expected to change the way in which clinical monitoring and trial management are conducted. According to the EMA, the new guideline will provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting.
Therefore, adoption of centralized Quality Risk Management and clinical research monitoring will be vital. Its advantages should be obvious, starting with the optimization of clinical data quality, subsequently achieving time and cost savings, and risk reduction at the end.
The new GCP ICH E6 (R2) Addendum introduced 26 new items covering three main areas of clinical research: sponsor and investigator responsibilities and risk-based monitoring. How can you comply with all of them?
1. To adopt the technology and practices in order to comply with the new requirements, sponsors should gather GCP experts to determine its outcome for the company.
2. With the compliance strategy ready, the company should define areas with persistent deficiencies. This gap analysis will help them determine a plan for change and the steps needed to get there.
3. Many sponsors still use various systems for data capturing, which can easily lead to overlooking the risks. Designing one integrated system with all the data will create real-time risk monitoring across the entire trial site network.
4. Cultural transformation is one of the biggest challenges companies face. Creating a centralized approach and sharing case studies of successful switching among organizations not only can help reduce monitoring time and cut costs but also uncover new risks.
5. Besides the responsibility for the quality, safety and efficacy of the clinical trial, the sponsor should always oversee the activities of CROs to be sure its approaches will meet the new ICH requirements.
To close the gap in order to comply with the new GCP ICH E6 (R2) addendum, join the upcoming 2nd Annual Clinical Quality & Compliance conference, taking place on 14 – 15 June 2017 in Prague.
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