Table 1 List of automatic and manual triggers with categories and abridged narratives
Trigger ID | Typea | Category | Abridged narrative | Firing rateb |
|---|---|---|---|---|
Trial 1 | ||||
1 | Au | Protocol deviation (treatment) | Drug dose greater than expected dose | 77% |
2 | Au | Data query rate (specific question) | Number of missing values of a specific field greater than a given percentage of the total of corresponding forms | 2% |
3 | Au | SAE rate (high) | Number of patients with SAEs is greater than expected | 0% |
4 | Au | High recruitment | Site has recruited more patients than a set target | 11% |
5 | Au | Data query rate (overall) | Number of queried fields greater than a given percentage of the total number of available fields | 4% |
6 | Au | Data query resolution time | Queried fields outstanding for more than a specified time greater than a given percentage of the total of queried fields | 26% |
7 | Au | Overall CRF return rate | CRF return rate less than a given value | 16% |
8 | Au | Protocol deviation (eligibility) | Enrolment of ineligible patient (date of surgery) | 8% |
9 | Au | Protocol deviation (eligibility) | Enrolment of ineligible patient (date of bloods) | 22% |
10 | Au | Protocol deviation (eligibility) | Enrolment of ineligible patient (date of scan) | 24% |
M1 | Mn | General concern | General concern from protocol deviation log | 2% |
Trial 2 | ||||
1 | Au | SAE rate (low) | Number of patients with SAEs is less than expected | 4% |
2 | Au | High recruitment | Site has recruited more patients than a set target | 0% |
3 | Au | Data query rate (overall) | Number of queried fields greater than a given percentage of the total number of available fields | 7% |
4 | Au | Data query resolution time | Queried fields outstanding for more than a specified time greater than a given percentage of the total of queried fields | 31% |
5 | Au | Overall CRF return rate | CRF return rate less than a given value | 4% |
6 | Au | Protocol deviation (treatment) | Drug (1) dose greater than expected dose | 0% |
7 | Au | Protocol deviation (treatment) | Drug (2) dose greater than expected dose | 1% |
8 | Au | Protocol deviation (treatment) | Drug (3) dose greater than expected dose | 0% |
9 | Au | Protocol deviation (treatment) | Drug (4) dose greater than expected dose | 0% |
10 | Au | Protocol deviation (treatment) | Drug (4) given when data indicate it should have been withheld | 43% |
11 | Au | Protocol deviation (treatment) | Drug (5) dose greater than expected dose | 0% |
12 | Au | Protocol deviation (withdrawal rate) | Number of withdrawn patients more than a given percentage of the total number of patients | 3% |
13 | Au | Protocol deviation (treatment) | Drug not given at correct dose | 0% |
M1 | Mn | General concern | General concern following Trial Management Group meetings | 2% |
M2 | Mn | Protocol deviation (procedure) | Important safety test missed | 0% |
M3 | Mn | Protocol deviation (treatment) | Medication is not administered when a particular test result is below a specified value | 0% |
M4 | Mn | Protocol deviation (treatment) | Drug (3) not given at correct dose in feasibility study centres | 0% |
Trial 3 | ||||
1 | Au | Return rate, specific CRF | If death reported, has the relevant form been sent? | 2% |
2 | Au | Return rate, specific CRF | If progression reported, has the relevant progression CRF been sent? | 43% |
3 | Au | Overall CRF return rate | CRF return rate less than a given value | 55% |
4 | Au | Return rate, specific CRF | More than a specified number of patients with last form received more than a given time | 5% |
5 | Au | Data query rate (overall) | Number of queried fields greater than a given percentage of the total of available fields | 2% |
6 | Au | Data query resolution time | Queried fields outstanding for more than a specified time greater than a given percentage of the total of queried fields | 47% |
7 | Au | SAE rate (low) | Number of patients with SAEs is less than expected | 18% |
8 | Au | SAE rate (high) | Number of patients with SAEs is greater than expected | 3% |
M1 | Mn | Return rate, patient consent form | Consent forms return rate less than a given value | 23% |
M2 | Mn | General concern | General concern following Trial Management Team review | 1% |