Question|Tick box option/ Question subsection|Variable name|Data entry format|List Options|Comment
||ctudummyid|||ID number replacing CTU identifier
1.    Please enter your CTU name or registration number|N/A|q1freetext|freetext||Removed as contains CTU identifier
2.    What is the most common number of sites in your randomised phase III CTIMP trials? |N/A|q2siteno|list|1-10; 11-49; 50+|
3.    What size randomised phase III CTIMP trials does your CTU usually conduct?  |N/A|q3patno|list|1-100;101-1000; 1001-2499; 2500+|
4.    Does your CTU conduct international trials ?|N/A|q4outuk|list|Yes; No|
5.    Does your CTU conduct an assessment of risk to inform your monitoring approach?|N/A|q5|list|Yes; Sometimes; No|
6.    Space for any comments on the questions above about randomised phase III CTIMP trials in your CTU |N/A|q6freetext|freetext||CTU identifiers redacted
7.    Does your CTU use centrally available data to formally evaluate site/trial performance?|N/A|q7|list|Yes; No|
8.    Does your CTU use a centralised monitoring process to guide, target or supplement on-site visits?|N/A|q8|list|Always; Frequently; Sometimes; Never|
9.    Does your CTU use a centralised monitoring process to replace on-site visits?|N/A|q9|list|Always; Frequently; Sometimes; Never|
10.    How do you program central monitoring for each trial?|N/A|q10|list|Bespoke software is written for each trial; The same software is used for every trial in the CTU; Pre-written modules are chosen for each trial with some bespoke programming; Central monitoring is not programmed|
11.    How often do you run central monitoring reports or software? |a.    Daily|q11daily|tick box|Yes|
11.    How often do you run central monitoring reports or software? |b.    Weekly, fortnightly or every 3 weeks|q11weeklyfortnightlyorevery|tick box|Yes|
11.    How often do you run central monitoring reports or software? |c.     Monthly|q11monthly|tick box|Yes|
11.    How often do you run central monitoring reports or software? |d.    Every 2-4 months|q11every24months|tick box|Yes|
11.    How often do you run central monitoring reports or software? |e.    Every 5-9 months |q11every59months|tick box|Yes|
11.    How often do you run central monitoring reports or software? |f.     Annually|q11annually|tick box|Yes|
11.    How often do you run central monitoring reports or software? |g.    Linked to an event e.g. DSMC, final analysis|q11linkedtoaneventegdsmcf|tick box|Yes|
11.    How often do you run central monitoring reports or software? |h.    Ad hoc|q11adhoc|tick box|Yes|
12.    If you use triggered on-site monitoring, is the trigger:|N/A|q12|list|Software generated; Partial software; Human assessed; Not applicable|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|a.    Consent issues|q13consentissues|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|b.    Number of protocol deviations|q13numberofprotocoldeviation|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|c.     Incidence of adverse events|q13incidenceofadverseevents|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|d.    Suspected fraud|q13suspectedfraud|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|e.    Missing CRF|q13missingcrf|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|f.     Number of data queries|q13numberofdataqueries|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|g.    Number of unanswered queries|q13numberofunansweredqueries|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|h.    Rate of enrolment (either quicker or slower than expected)|q13rateofenrolmenteitherqui|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|i.      Participant dropout rate|q13participantdropoutrate|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|j.     Screen failure rate|q13screenfailurerate|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|k.    Laboratory data signals|q13laboratorydatasignals|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|l.      Lack of experience with site|q13lackofexperiencewithsite|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|m.   Number of eligible individuals who consented|q13numberofeligibleindividua|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|n.    Number of patients with complete data for primary and important secondary outcomes|q13numberofpatientswithcompl|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|o.    Number of patients who started allocated intervention|q13numberofparticipantswhost|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|p.    Not applicable|q13notapplicable|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|q.    Other|q13other|tick box|Yes|
13.    Which of the following factors would be likely to trigger a site monitoring visit?|Other, specify|q13otherother|freetext||
14.    However you agree a final trigger for an on-site visit, do you always action an on-site visit?|N/A|q14|list|Yes; No; Not applicable|
15.    Do you use information from routine electronic health records to compare against data captured in the trial database? |N/A|q15|list|Yes; No|
16.    Please provide any further comments, clarifications or elaboration on your answer or anything you wish to add about Central Monitoring |N/A|q16freetext|freetext||
17.    Does your CTU perform on-site monitoring visits?|N/A|q17|list|Always; Frequently; Sometimes; Never|
18.    Who visits the site to monitor?|a.    Trial coordinator/manager|q18trialcoordinatormanager|tick box|Yes|
18.    Who visits the site to monitor?|b.    Trial assistant|q18trialassistant|tick box|Yes|
18.    Who visits the site to monitor?|c.     Data manager|q18datamanager|tick box|Yes|
18.    Who visits the site to monitor?|d.    Monitor |q18monitor|tick box|Yes|
18.    Who visits the site to monitor?|e.    Quality assurance lead|q18qualityassurancelead|tick box|Yes|
18.    Who visits the site to monitor?|f.     Quality assurance team member|q18qualityassuranceteammembe|tick box|Yes|
18.    Who visits the site to monitor?|g.    Programmer|q18programmer|tick box|Yes|
18.    Who visits the site to monitor?|h.    Chief Investigator|q18chiefinvestigator|tick box|Yes|
18.    Who visits the site to monitor?|i.      Pharmacist|q18pharmacist|tick box|Yes|
18.    Who visits the site to monitor?|j.     CRO|q18cro|tick box|Yes|
18.    Who visits the site to monitor?|k.    Other |q18other|tick box|Yes|
18.    Who visits the site to monitor?|Other, specify|q18otherother|freetext||
19.    How long is your average site visit?|N/A|q19|list|Up to 4 hours; One day; More than 1 day|
20.    How many people are generally sent on a site visit?|N/A|q20|list|One; Two; Three; Four or more|
21.    How do you decide when to visit a site?|a.    When triggered|q21whentriggered|tick box|Yes|
21.    How do you decide when to visit a site?|b.    Fixed time period (e.g. annually, every 6 months)|q21fixedtimeperiodegannua|tick box|Yes|
21.    How do you decide when to visit a site?|c.     Number of patients (e.g. every 10 patients recruited)|q21numberofpatientsegever|tick box|Yes|
21.    How do you decide when to visit a site?|d.    Linked to a trial event (e.g. site initiation, SAE)|q21linkedtoatrialeventegs|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|a.    Study design|q22studydesign|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|b.    Critical study requirements/procedure|q22criticalstudyrequirements|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|c.     Monitoring plan in protocol|q22monitoringplaninprotocol|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|d.    SOPs|q22sops|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|e.    Usual practice|q22usualpractice|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|f.     Pre-defined analysis of risks|q22predefinedanalysisofrisk|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|g.    Study population|q22studypopulation|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|h.    Budget|q22budget|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|i.      Other |q22other|tick box|Yes|
22.    The frequency of your trials on-site monitoring visits is most commonly determined by:|Other, specify|q22otherother|freetext||
23.    How often do you visit each site?|a.    Only when triggered|q23onlywhentriggered|tick box|Yes|
23.    How often do you visit each site?|b.    At least every 3 years|q23atleastevery3years|tick box|Yes|
23.    How often do you visit each site?|c.     At least very 2 years|q23atleastevery2years|tick box|Yes|
23.    How often do you visit each site?|d.    At least annually|q23atleastannually|tick box|Yes|
23.    How often do you visit each site?|e.    At least 6 monthly|q23atleast6monthly|tick box|Yes|
23.    How often do you visit each site?|f.     At least monthly|q23atleastmonthly|tick box|Yes|
24.    What percentage of each of the following do you source data verify? |All data|q24all|integer||
24.    What percentage of each of the following do you source data verify? |Consent|q24consent|integer||
24.    What percentage of each of the following do you source data verify? |Eligibility criteria|q24elig|integer||
24.    What percentage of each of the following do you source data verify? |Primary endpoint reports|q24po|integer||
24.    What percentage of each of the following do you source data verify? |Secondary endpoint reports|q24so|integer||
24.    What percentage of each of the following do you source data verify? |SAE – Serious adverse events|q24sae|integer||
24.    What percentage of each of the following do you source data verify? |AE – Non-serious adverse event reports|q24nsae|integer||
24.    What percentage of each of the following do you source data verify? |Selected priority data|q24priority|integer||
25.    During on-site monitoring visits, do you:|Assess staff’s understanding of study procedures|q25understand|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Assess the ability of staff to explain study to participants|q25explain|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Assess the adequacy and timelines of additional information provided to participants|q25adeqtime|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Assess informed consent updates/modifications|q25consmod|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Verify CRF data versus source documents|q25sdv|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Assess regulatory documents and communications|q25regcom|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Assess the security of study data and documentation|q25sec|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Check the site file is complete|q25complete|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
25.    During on-site monitoring visits, do you:|Check adherence to GDPR|q25gdpr|list|Always; Frequently; Occasionally; Never; N/A; Not sure|
26.    Please provide any further comments, clarification or elaboration on your answers or anything you wish to add about on-site monitoring|N/A|q26freetext|freetext||CTU identifiers redacted
27.    Which aspect of monitoring would you most like to change?|N/A|q27|list|Stop or reduce the number of on-site visits; Stop or reduce SDV; Optimise central monitoring; Other|
27.    Which aspect of monitoring would you most like to change?|Other, specify|q27otherother|freetext||
28. If you would like to be contacted with the result of the questionnaire, please give your email address here|N/A|q28freetext|freetext||Removed as contains identifier