Table 3.
Comparison of RPNs for14 high-risk failure modes before and after the quality improvement initiative was implemented
| Core process | Failure mode | S | O | D | Baseline RPN | Remedial action plan | S | O | D | Reassessed RPN | % change* |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Obtaining informed consent | CRCs do not check whether the IRB approval date on the ICF is most up-to-date. Instead, they use an outdated version of subject information sheet and the ICF. | 9 | 7 | 6 | 378 | To grant CRCs an authority to get access to the clinical trials management system so that they can directly check whether the ICF is most up-to-date and IRB-approved. | 7 | 1 | 2 | 14 | −96.3 |
| Investigators do not ask if a clinical trial participant had any additional questions about the study before they sign the ICF at the first time. The investigator do not document issues discussed during the informed consent obtaining session. Subjects cannot or do not ask a question. |
7 | 7 | 4 | 196 | To develop a system by which clinical trial participants can consent and sign the ICF on an individual basis such as making a room available for them where they can ask any clinical trial-related question for investigators and get those answered. | 7 | 7 | 4 | 196 | 0.0 | |
| Clinical trial participants do not take sufficient time to decide whether to participate in the study before they sign the ICF. | 7 | 7 | 4 | 196 | To develop a system by which clinical trial participants can consent and sign the ICF on an individual basis such as making a room available for them where they can ask any clinical trial-related question for investigators and get those answered. | 7 | 7 | 4 | 196 | 0.0 | |
| Because CRCs use an outdated version of the ICF, clinical trial participants do not get the most up-to-date information about the study and study drug in a timely manner. | 9 | 5 | 6 | 270 | To grant CRCs an authority to get access to the clinical trials management system so that they can directly check whether the clinical protocol and study-related information is most up-to-date and IRB-approved. | 9 | 2 | 2 | 38 | −85.9 | |
| Investigators do not ask if a clinical trial participant had any additional questions about the study before they sign the ICF at re-consenting. The investigator do not document issues discussed during the informed consent obtaining session. Subjects cannot or do not ask a question. | 7 | 7 | 4 | 196 | To develop a system by which clinical trial participants can consent and sign the ICF on an individual basis such as making a room available for them where they can ask any clinical trial-related question for investigators and get those answered. | 7 | 7 | 4 | 196 | 0.0 | |
| Document management, including source documents and essential documents | Required essential documents are not filed appropriately. Filing is done without standards or a proper archiving system. | 8 | 7 | 5 | 280 | To grant CRCs an authority to get access to the clinical trials management system so that they can directly check whether the clinical protocol is most up-to-date and IRB-approved. | 4 | 2 | 3 | 24 | −91.4 |
| Missing, incomplete, or outdated essential documents in the SMF. Essential documents are not separately filed by their version. | 7 | 7 | 5 | 245 | To grant CRCs an authority to get access to the clinical trials management system so that they can directly check whether the clinical protocol is most up-to-date and IRB-approved. | 4 | 2 | 3 | 24 | −90.2 | |
| Essential documents are not checked for completeness. | 7 | 7 | 6 | 245 | Investigators and CRCs to review all of the study-related documents after study completion. | 4 | 2 | 3 | 24 | −90.2 | |
| Source documents are not reviewed or signed in a timely manner. | 7 | 7 | 5 | 245 | CRCs to notify investigators to sign off all of the study-related documents within 3 weeks after the completion of the clinical trial. | 5 | 1 | 3 | 15 | −93.9 | |
| Sitepersonneltraining | Lists of required qualification/training/experience of site personnel are missing. | 7 | 4 | 7 | 196 | To develop a clinical trial center-wide tracking system for individual history of training and education. | 7 | 3 | 3 | 63 | −67.9 |
| New staff do not complete the assigned training and education within the pre-specified timeline. Training for new staff are inconsistent or inadequate. | 9 | 4 | 7 | 252 | The clinical trials center director to have the QI team to double check for a new employee to complete the assigned education and training within 4 weeks of employment. | 7 | 2 | 3 | 42 | −83.3 | |
| Incomplete or inadequate study-specific training. | 9 | 5 | 5 | 225 | To develop a new online or paper-based tracking system and log for continuous education and training. | 7 | 2 | 3 | 42 | −81.3 | |
| The training folder in the SMF is not updated in a timely manner. Incomplete or inadequate training records are found in the SMF. | 5 | 9 | 7 | 315 | The QI team to request the education and training completion logs every month. | 5 | 2 | 3 | 30 | −90.5 | |
| The annual training plan is not evaluated regularly for its appropriateness. Additional training plans do not incorporate the results of the evaluation. | 7 | 7 | 5 | 245 | The QI team to conduct a bi-annual status assessment of education and training. | 5 | 4 | 4 | 80 | −67.3 | |
| Mean (SD) | 7.50 (1.16) | 6.43 (1.40) | 5.43 (1.09) | 257.67 (48.60) | 6.07 (1.54) | 3.14 (2.21) | 3.14 (0.66) | 49.33 (20.33) | −90.5 |
Notes:
*
Percent change in RPN from baseline. (−) denotes reduction in RPN.
Abbreviations: CRC, clinical research coordinator; D, detection score; ICF, informed consent form; IRB, institutional review board; O, occurrence score; QI, quality improvement; RPN, risk priority number; S, severity score; SMF, site master file.