Skip to main content

Table 1 List of automatic and manual triggers with categories and abridged narratives

From: Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

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%
  1. CRF: case report form, SAE: serious adverse event
  2. aType of trigger: Au: automatic; Mn: manual
  3. bFiring rate: proportion of assessments in which the trigger was fired