ctudummyid|q2siteno|q3patno|q4outuk|q5|q6freetext|q7|q8|q9|q10|q11daily|q11weeklyfortnightlyorevery|q11monthly|q11every24months|q11every59months|q11annually|q11linkedtoaneventegdsmcf|q11adhoc|q12|q13consentissues|q13numberofprotocoldeviation|q13incidenceofadverseevents|q13suspectedfraud|q13missingcrf|q13numberofdataqueries|q13numberofunansweredqueries|q13rateofenrolmenteitherqui|q13participantdropoutrate|q13screenfailurerate|q13laboratorydatasignals|q13lackofexperiencewithsite|q13numberofeligibleindividua|q13numberofpatientswithcompl|q13numberofparticipantswhost|q13notapplicable|q13other|q13otherother|q14|q15|q16freetext|q17|q18trialcoordinatormanager|q18trialassistant|q18datamanager|q18monitor|q18qualityassurancelead|q18qualityassuranceteammembe|q18programmer|q18chiefinvestigator|q18pharmacist|q18cro|q18other|q18otherother|q19|q20|q21whentriggered|q21fixedtimeperiodegannua|q21numberofpatientsegever|q21linkedtoatrialeventegs|q22studydesign|q22criticalstudyrequirements|q22monitoringplaninprotocol|q22sops|q22usualpractice|q22predefinedanalysisofrisk|q22studypopulation|q22budget|q22other|q22otherother|q23onlywhentriggered|q23atleastevery3years|q23atleastevery2years|q23atleastannually|q23atleast6monthly|q23atleastmonthly|q24all|q24consent|q24elig|q24po|q24so|q24sae|q24nsae|q24priority|q25understand|q25explain|q25adeqtime|q25consmod|q25sdv|q25regcom|q25sec|q25complete|q25gdpr|q26freetext|q27|q27otherother 1|1-10|101-1000|Yes|Yes||Yes|Frequently|Frequently|Bespoke software is written for each trial|||Yes||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||||Yes|Yes|||||Yes|Previous monitoring visits not closed or change in key staff|Yes|Yes|Central monitoring is defined in our monitoring plans based on the risk assessment for the trial.|Always|Yes||Yes|Yes||Yes|||||||One day|One|Yes|Yes|Yes|Yes||Yes|Yes|Yes||Yes|||||Yes|||Yes|||20|100|50|100|100|100|100|100|Frequently|Occasionally|Frequently|Always|Always|Always|Always|Always|Frequently|If a site has had a change in key staff, a high number of deviations or the monitor has identified that the staff are lacking some understanding of trial procedures the Project Manager and/or data manager will provide extra training at the site separately from the monitoring visit.|Stop or reduce SDV| 2|11-49|1001-2499|Yes|Yes|We support more non CTIMP studies. The Phase III CTIMP study we supported 5 years back was conducted only in UK. At that time we didn't have risk based monitoring approach, but we do now. |Yes|Always|Never|Pre-written modules are chosen for each trial with some bespoke programming|||||||Yes||Human assessed|Yes|Yes||Yes|||||||Yes||||||Yes|Potentially it can be most of the above options depending on the severity.|Yes|Yes||Always||||Yes||Yes|||||||One day|One|Yes|Yes||Yes|Yes|Yes|Yes|Yes||Yes||||||||Yes|Yes|||100|100|10|10|100|10|10|Always|Occasionally|Frequently|Always|Always|Always|Always|Always|Always||Optimise central monitoring| 3|11-49|1-100|No|Yes||Yes|Frequently|Frequently|Central monitoring is not programmed||||Yes|||Yes|Yes|Human assessed|Yes|Yes|Yes|||Yes|Yes|||||Yes|||||||Yes|No||Sometimes|Yes||||||||||||Up to 4 hours|One|Yes|Yes|Yes|||Yes|Yes|||Yes|||||Yes|||Yes|Yes|||||||||100|Always|Never|Occasionally|Always|Always|Always|Always|Always|Frequently||Optimise central monitoring| 4|11-49|101-1000|No|Sometimes||Yes|Sometimes|Sometimes|Central monitoring is not programmed||Yes|||||Yes||Human assessed|Yes|Yes||Yes||Yes|Yes|||||Yes|||||||Yes|No||Sometimes|Yes||||||||||||One day|One|Yes|||Yes|Yes||Yes||||||||Yes|||||||100|100||||||Always|Frequently|Never|Occasionally|Occasionally|Frequently|Occasionally|Frequently|Occasionally||Optimise central monitoring| 5|50+|101-1000|Yes|Yes||Yes|Sometimes|Sometimes|Central monitoring is not programmed|||||||||Human assessed|Yes|Yes|Yes|Yes||Yes|Yes|Yes||||||Yes|||||Yes|No||Frequently|Yes|||Yes||||||Yes|||More than 1 day|Two|Yes|||Yes|Yes|Yes|Yes|Yes||Yes|||||Yes|||Yes|||||||||||Always|Never|Always|Always|Frequently|Occasionally|Occasionally|Frequently|Occasionally||Optimise central monitoring| 6|50+|1001-2499|Yes|Yes|we do relatively few phase 3|Yes|Frequently|Sometimes|The same software is used for every trial in the CTU||||||||Yes||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| 7|50+|101-1000|Yes|Yes|Phase III trials span from 170 pts to 4000+ pts|Yes|Sometimes|Never|Central monitoring is not programmed|||||||Yes||Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||||||||||||Yes|No||Frequently|Yes||Yes|Yes||||||Yes|||More than 1 day|One|Yes|Yes|Yes|||||||||Yes|Yes|Trial Specific Risk Assessment |Yes||Yes||||||||||||Frequently|Occasionally|Occasionally|Always|Always|Always|Frequently|Always|Frequently|The % of SDV is determined on a per trial basis in line with the risk assessment. It is not possible to provide generalised figures as it can vary significantly. The actions undertaken during on-site monitoring are affected by whether it is a triggered monitoring visit vs a routine monitoring visit. A triggered monitoring visit would focus on the area where the issue was identified and in some cases this could be Pharmacy or Imaging for example.|Optimise central monitoring| 8|11-49|101-1000|Yes|Yes||Yes|Frequently|Never|Central monitoring is not programmed||||Yes|||||Human assessed|Yes|Yes|Yes||Yes|Yes|||Yes||||Yes|Yes|Yes||||Yes|Yes|With regard to question 15 - this is only for 1 study. 1 more planned|Always||||Yes|||||||||One day|One|Yes||||Yes|||Yes||Yes|||||Yes|||||||100|||||||Occasionally|Never|Never|Frequently|Always|Frequently|Frequently|Always|Never|I can't complete the SDV question as this is determined on a trial by trial basis as part of the monitoring plan. For some trials we do a lot of SDV for others we may only check primary outcome measures for 2 patients at each site. Our main reason for on site monitoring is to assess protocol compliance this is missing off your list.|Optimise central monitoring| 9|50+|1001-2499|No|No|Whilst our CTU doesn't currently conduct an assessment of risk - all our CTIMPs are locally sponsored and risk assessed by the sponsor |Yes|Sometimes|Always|Pre-written modules are chosen for each trial with some bespoke programming|||Yes||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes|||||Yes|||Yes||||Yes|No||Sometimes|Yes||||||||||||One day|One|Yes|||Yes|||||Yes||||||Yes|||Yes||||||10|||||Frequently||||Frequently|Occasionally|Occasionally|Frequently||The results of this survey are a combined response from 3 Trial managers who work on 3 different CTIMPs - so some responses are consistent for all 3 studies, whereas others might just be from 1 of the trials|Optimise central monitoring| 10|50+|1001-2499|Yes|Yes||Yes|Always|Sometimes|Central monitoring is not programmed|||||||Yes|Yes|Human assessed|Yes|Yes||Yes|||Yes|||||||Yes|||||Yes|Yes|Triggers for on-site monitoring are detailing in the trial's monitoring plan and will generally focus on what's important for the particular trial|Frequently|Yes||Yes||||||||||More than 1 day|Two|Yes||Yes|Yes|Yes||Yes|||Yes||Yes|||Yes||||||||||||||Frequently|Not sure|Not sure|Always|Always|Always|Not sure|Always|Frequently|The percentages for source data verification vary from trial to trial and will be detailed in the monitoring plan for the trial|Optimise central monitoring| 11|11-49|101-1000|Yes|Yes|At present there is only one active study with a single non-UK site (this is in set-up).|Yes|Frequently|Sometimes|Central monitoring is not programmed|||Yes||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|||||||||Yes|Inappropriate IMP administration |Yes|Yes|Some of the factors to trigger a visit would be in combination, e.g. sites that generate a high volume of data queries which are not resolved in a timely manner or, if any factors occured for long periods of time and caused concern. |Frequently|Yes||Yes||||||||Yes|Clinical Project Manager (inc. the CPM for monitoring) as required.|One day|One|Yes|Yes||Yes||Yes|Yes|||Yes||Yes|Yes|According to CTIMP risk category (A, B, C). |Yes|||Yes|||5|100|5|5|5|5|5|5|Occasionally|Occasionally|Occasionally|Frequently|Always|Always|Always|Frequently|Not sure|The percentage of data review- is dependant on the number of pts recruited at the site. General guidance is usually 5 pts per site.|Optimise central monitoring| 12|50+|2500+|Yes|Yes|I have answered the questions on the prior page in relation to our large scale International trials, however we also run single site phase 3 trials. A risk based monitoring approach would be used for all trials, regardless of scale or phase, which would be factored into the risk assessment. |Yes|Sometimes|Never|Bespoke software is written for each trial|||Yes|Yes|||Yes|Yes|Not Applicable||||||||||||||||||||No|We have not run a trial to date where on-site monitoring visits have been triggered by central monitoring, but we are moving more towards this approach and it is likely this would be the case for our next multi-site phase 3 trial. |Frequently||||Yes|Yes|||||Yes|||One day|One|||Yes|Yes|Yes|Yes||||Yes|Yes|||||||Yes|Yes||||||||||Occasionally|Never|Frequently|Frequently|Frequently|Frequently|Occasionally|Frequently|Occasionally|I have not answered the question in relation to % of source data verification as this is very much determined by the risk assessment and varies for each trial. Some Sponsors continue to mandate 100% SDV, and do not permit a risk based approach. |Optimise central monitoring| 13|1-10|101-1000|Yes|No|Our Sponsor does the risk assessment to decide on the level of monitoring.|Yes|Frequently|Sometimes|Bespoke software is written for each trial|||||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||Yes||Yes|||Yes|Yes||||Yes|No|Our Sponsor is responsible for monitoring. They do not use Central Monitoring. However, we use some Central Monitoring techniques, particularly in TSC reports etc, and would augment Sponsor instructions with this.|Sometimes|Yes|||Yes|||||||||One day|One|Yes||Yes|Yes||||||Yes||||||||||||30||100||100|||Always|Never|Never|Always|N/A|Frequently|Occasionally|Frequently|Occasionally||Optimise central monitoring| 14|11-49||Yes|Yes||No|Never|Never|Central monitoring is not programmed|||||||Yes||Not Applicable|Yes|Yes|Yes|Yes||Yes|Yes||||||Yes|Yes|||||Yes|Yes|This trial unit does not utilise central monitoring|Always||||Yes|||||||||More than 1 day|One||Yes|||Yes|Yes|Yes|||||Yes||||||Yes|||25|100|100|100||100|25||Always|Occasionally|Always|Always|Always|Always|Occasionally|Always|Always||Stop or reduce the number of on-site visits| 15|11-49|1001-2499|Yes|Yes|Difficult to answer Q3 - some of our phase 3 IMP trials have had a couple hundred participants, others have had a couple thousand. We don't have very many current phase 3 IMP trials.|Yes|Always|Sometimes|Pre-written modules are chosen for each trial with some bespoke programming||Yes|Yes||||Yes|Yes|Partial software|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes||Yes|Updated documents not being sent or delays in obtaining/sending i.e. delegation log/CVs/GCPs. Re-training required.IMP accountability or Pharmacy issues.|Yes|Yes|A mixture of electronic and paper health records / study notes are used for source-data-verification. Paper CRFs or worksheets may also be used by sites before transcribing to the trial database, which are also verified.|Frequently|Yes|||Yes|||||||||One day|One|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|No. of monitors assigned to studies. Risk assessment (low/medium/high) resulting in different levels of SDV required|Yes|||Yes|Yes||20|100|100|100|20|100|20|100|Always|Not sure|N/A|Always|Frequently|Frequently|Frequently|Frequently|Always|Monitoring is based on overall risk assessment of study and any high risk elements which will require higher levels of monitoring. Overall risk assessment: Low risk = 20% SDV Medium risk = 50% SDV High risk = 100% SDV Additionally the first two participants' data at every site undergo 100% SDV. Q24 has been answered as if the study in question would be low risk.|Optimise central monitoring| 16|11-49|101-1000|Yes|Yes||Yes|Frequently|Sometimes|The same software is used for every trial in the CTU||Yes|Yes|Yes|||||Human assessed|Yes|||Yes|||Yes|Yes|Yes|Yes||Yes||Yes|||||Yes|No||Frequently|Yes|||Yes|||||||||One day|One|Yes|Yes|Yes|Yes|Yes|Yes||||Yes|||||Yes|Yes|||||||||||||Occasionally|Frequently|Frequently|Always|Always|N/A|Occasionally|Frequently|Never|Unable to complete section on % as it depends on the study - decisions are risk based. |Optimise central monitoring| 17|50+|101-1000|Yes|Yes|We have very few international trials, routinely we do not run CTIMPs that are international |Yes|Frequently|Frequently|Central monitoring is not programmed||Yes|||||||Human assessed|Yes|Yes|Yes||Yes|Yes|Yes||||||||||||Yes|No|Triggers are generally tracked usual and excel spreadsheet which comes up with a cumulative score. This is a process that is in development currently and is still being adapted in the phase III setting |Sometimes||||Yes|||||||||One day|One|Yes||Yes||Yes||Yes|||Yes||Yes|||Yes|||Yes||||100|100|||100|100|100|Frequently|Occasionally|Occasionally|Always|Always|Occasionally|Frequently|Always|Always||Optimise central monitoring| 18|1-10|101-1000|Yes|Yes||No|Sometimes|Sometimes|The same software is used for every trial in the CTU|||Yes|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| 19|11-49|101-1000|Yes|Yes|The number of patients per site can vary considerably. Although we have a few trials with high sample size the majority are a few hundred and can be split across a large number of sites. |Yes|Always|Frequently|Bespoke software is written for each trial|||Yes|Yes||Yes|Yes||Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||Yes|||||Yes|||||Yes|Yes|Some of the aspects for a triggered visit on the previous page not selected would trigger contact. For example consent or screen rates would usually result in phone calls first. Wasn't clear to me what you meant by software for monitoring- I answered yes but this is very much stats programming rather than anything more complex. We use our risk assessment to consider the frequency of monitoring reports. A trial recruiting few patients per month with low safety profile would have fewer reports than if safety or recruitment rates were higher |Sometimes|Yes||Yes|||||Yes|||||One day|Two|Yes|||Yes|Yes|Yes|Yes|||Yes|Yes||||Yes||||||||||10|||100|Always|Occasionally|Occasionally|Frequently|Frequently|Frequently|Frequently|Frequently|Frequently|Our on-site visits are usually triggered. When they are triggered we prioritise what we will look at based on concerns and address as much as possible within that day without compromising the resolution of the immediate concern. Sometimes the visits are actually to support sites with data query backlogs. |Stop or reduce SDV| 20|11-49|1001-2499|Yes|Yes|We have a cancer program with more sites and patients ( UK ) and an infections program with less sites and patients ( mainly non-UK)|Yes|Always|Never|Pre-written modules are chosen for each trial with some bespoke programming|||Yes||||Yes||Human assessed|Yes|Yes|Yes|Yes|Yes||Yes||||||||||||No|No||Always|Yes||Yes||||||||Yes|local monitor|More than 1 day|Two|Yes|||Yes|||Yes|||Yes||Yes|||Yes|||Yes|||0|100|100|100|0|100|0|0|Frequently|Occasionally|Occasionally|Always|Always|Frequently|Always|Frequently|Frequently|we have cancer trials with large sites and small numbers per site leading to less on site visits. Then we have infection trials with few sites (10) and many patients per site where we visit annually.|Optimise central monitoring| 21|11-49|1001-2499|Yes|Yes||Yes|Always|Frequently|Bespoke software is written for each trial||Yes|||||||Human assessed||Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|||Yes|Yes||Yes||||No|Yes||Frequently|Yes|||Yes|Yes|Yes||Yes|||||One day|One|Yes|Yes|Yes||Yes||Yes|||Yes||Yes|||Yes||||||||||||||Occasionally|Never|Never|Never|Frequently|Frequently|Occasionally|Frequently|Frequently||Optimise central monitoring| 22|11-49|101-1000|No|Yes|A risk assessment would be completed by the Sponsor but the CTU would feed into the risk assessment.|Yes|Sometimes|Sometimes|Central monitoring is not programmed|||Yes||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|||Yes|||||Yes||Yes|||||Yes|Yes||Frequently|Yes|||Yes|||||||||One day|One|Yes|Yes|Yes|Yes|Yes|Yes||||Yes|||||Yes|||Yes|||20|100|100|100|100|100|100||Frequently|Never|Occasionally|Always|Always|Always|Always|Always|Never||Optimise central monitoring| 23|11-49|101-1000|Yes|Yes||Yes|Always|Frequently|Central monitoring is not programmed||||||Yes|Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes||||||||||||||Yes|No||Sometimes|Yes|Yes|||Yes||||||||One day|One|Yes||Yes||||Yes|||Yes||Yes|||Yes|||Yes|||30|100|30|30|0|30|30|0|Occasionally|Never|Never|Always|Frequently|Frequently|Frequently|Frequently|Never||Optimise central monitoring| 24|11-49|101-1000|Yes|Yes|We have generally run phase IV trials in the past.|Yes|Sometimes|Sometimes|Bespoke software is written for each trial||Yes|Yes||||||Partial software|Yes||Yes|Yes||Yes|Yes|Yes||||Yes|||||||Yes|No|If there are electronic health records at site then these will be used in the SDV process. They are not however checked centrally|Frequently|Yes|||Yes|||||||||One day|One|Yes|Yes|Yes||Yes|Yes|Yes|||Yes|||||Yes|||Yes||||50|50|||50|||Always|Always|Occasionally|Frequently|Always|Always|Frequently|Always|Frequently|Our monitoring frequency really depends on the trial. We have some trials we will only be using on site monitoring for, some we go to after the first so many patients, and some triggered. We will be scaling down our on site monitoring in replacement of central monitoring and uploading consent form. The percentages of things checked also depends on the study, some we do 10% SDV for, some smaller trials 100%.|Optimise central monitoring| 25|50+|2500+|Yes|Yes||Yes|Frequently|Sometimes|Bespoke software is written for each trial|Yes|Yes|||Yes||||Partial software|Yes|Yes|Yes|Yes|||||||Yes|Yes|||||||Yes|Yes|Use two systems: Process - run frequently, and statistical run 6 monthly - as data accrues.|Frequently||||Yes|Yes|Yes|||||||One day|One|Yes|Yes|||Yes|Yes|Yes|||Yes||Yes|||Yes|||Yes|||0|100|0|100|100|0|0|0|Always|Always|Occasionally|Frequently|Never|Occasionally|Occasionally|Frequently|Occasionally|On site monitoring includes participant interview observation and mentorship of the trial staff|Optimise central monitoring| 26|11-49|1-100|Yes|Yes||Yes|Frequently|Frequently|Central monitoring is not programmed|||||Yes||Yes|Yes|Human assessed|Yes|Yes||Yes|Yes||Yes|||Yes||Yes|||||||Yes|Yes||Sometimes|Yes|||Yes|Yes|Yes|||||||One day|One|Yes||Yes|Yes|Yes|Yes||||||Yes|||Yes|||||Yes|10|50|100|100|50|100|10|100|Frequently|Occasionally|Occasionally|Frequently|Always|Occasionally|Frequently|Always|Occasionally|I answered the questions in a very generic way; each trial has its own unique monitoring, so I'm not convince our answers are reflective fully of what actually happens.|Optimise central monitoring| 27|50+|101-1000|Yes|Yes||No|Sometimes|Sometimes|Central monitoring is not programmed||||Yes|||||Human assessed|Yes|Yes|Yes||||||||||||||||Yes|No||Sometimes|Yes||||||||||||Up to 4 hours|One|Yes|||Yes|||Yes|||Yes||Yes|||Yes||||||||||||||Frequently|Occasionally|Occasionally|Frequently|Frequently|Frequently|Frequently|Always|Frequently||Other|have funding fo rmore on site monitoring visits 28|11-49|101-1000|Yes|Yes|We have done a few international projects. Mostly phase IV trials and a few of phase III|Yes|Frequently|Sometimes|Central monitoring is not programmed|||Yes||||||Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes||||Yes|No|I create monitoring plans and not the programming. So can’t answer the software question for all the projects. Usually the data manager provides a system that allow to extract reports that are used on central monitoring.|Frequently|Yes|||||Yes|||||||One day|One|Yes|Yes|Yes||||Yes|||Yes||||||||Yes|||15|100|100|100|100|100|0|0|Always|Frequently|Frequently|Always|Always|Always|Always|Always|Always||Optimise central monitoring| 29|1-10|101-1000|No|Yes||Yes|Frequently||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| 30|11-49|101-1000|No|Yes||Yes|Frequently|Sometimes|Central monitoring is not programmed||Yes|Yes||||Yes|Yes|Human assessed||Yes||Yes|Yes|Yes|Yes|||||Yes|||||||Yes|No|Struggled a bit these questions. Until our new eDC system beds in (which specifically supports central monitoring and also targeting of onsite visits) we continue to interrogate our bespoke systems to evaluate site performance and identify grounds for undertaking on-site monitoring. This might include data around number of queries, time taken for data return, number of reported non-compliances etc. Outcome of this central monitoring is discussed at TMG meetings. |Sometimes|Yes||||||||||||One day|Two|Yes||Yes||Yes|Yes|Yes|||Yes|||||Yes|||Yes|Yes||||||||||Occasionally|Never|Never|Frequently|Frequently|Occasionally|Occasionally|Occasionally|Occasionally||Stop or reduce SDV| 31|11-49|101-1000|No|Yes|We only have 3 CTIMPs running (with a monitoring plan) at the moment, most of our trials are not CTIMPs|Yes|Always|Sometimes|The same software is used for every trial in the CTU|Yes|Yes|Yes||||||Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||Yes||Yes||Yes|Yes|Yes||||Yes|Yes||Always|Yes|Yes|||||||||||One day|One|Yes|Yes|Yes||Yes|||||Yes|||||Yes|||Yes|||10|100|100|100|10|10|10|10|Frequently|Occasionally|Occasionally|Always|Frequently|Frequently|Frequently|Frequently|Frequently|The CTIMP monitoring plans are usually determined by the Sponsor and so not always in our control.|Stop or reduce SDV| 32|11-49|101-1000|Yes|Yes|Currently have more early phase trials open|Yes|Sometimes|Sometimes|Central monitoring is not programmed||||||||Yes|Human assessed|Yes|Yes|Yes|Yes||Yes|Yes|Yes||||Yes|||||||Yes|Yes|Central monitoring process is currently being evolved by an internal working group. This will enable us to define central monitoring checks based on risk and when a triggered monitoring visit should be considered, and to get smarter in the use of central monitoring. All trials currently require a minimal low level SDV based on risk assessments or sponsor requirements, but this reflects the low number of late phase trials in oncology portfolio currently; new trials pending grant outcomes would consider central monitoring with triggers for SDV, based on risk assessments. In non-cancer portfolio, there are a number of trials which do not have any pre-planned monitoring visits and central monitoring is specified Regarding triggers for site visits, this is being addressed within our working group as we do not have a formalised process as yet so ad-hoc based on observed issues.|Frequently|Yes|||Yes|||||||||One day|One|Yes|Yes|Yes|Yes|Yes||Yes|Yes||Yes||Yes|||Yes|||Yes||||100|||||||Frequently|Never|Never|N/A|Always|N/A|Never|Occasionally|Never|Re % SDV, variable based on monitoring plan requirements. We review all consent forms in house, centrally, as sites send them to *NAME REDACTED*. If we perform a site monitoring visit, we would review 100% eligibility, but not necessarily for 100% of patients at that site. Monitoring plans stipulate the number of patients requiring SDV and the % of each data point. *SECTION REDACTED*. We pre-advise sites that they are responsible for their site files and are responsible for filing regulatory information we send to them. (We would like to tick all options in q27 but only allowed one)|Optimise central monitoring| 33|11-49|1001-2499|No|Yes|REDACTED TEXT|Yes|Frequently|Frequently|Central monitoring is not programmed||||Yes|||||Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes||Yes|||Yes||Yes|||||Not Applicable|No|All comments and answers relate to what we plan to do in our trials but has limited experience thus far.|Sometimes|Yes||||||||||||One day|One|Yes|||Yes|Yes|Yes|Yes|Yes||Yes|||||Yes|||Yes|||10|100|100|100|10|100|10|10|Always|Always|Always|Always|Always|Always|Always|Always|Always|As mentioned all answers relate to our plan for our trials|Optimise central monitoring| 34|1-10|1-100|Yes|Yes||Yes|Frequently|Sometimes|Central monitoring is not programmed|||Yes||||Yes|Yes|Not Applicable||||||||||||||||||||No|We have a small number of managed CTIMPs. Our processes for central monitoring are evolving and involve mainly non regulted research.|Frequently|Yes||||||||||||One day|One|Yes||Yes|Yes|Yes|Yes|Yes|||Yes||Yes|||Yes|||Yes|||50|100|100|100|60|100|10|0|Frequently|Frequently|Always|Always|Frequently|Frequently|Frequently|Frequently|Frequently|The percentage's of data monitored vary per study and are dependent on risk, location and triggers mainly. These processes are very much evolving at *NAME REDACTED*|Optimise central monitoring| 35|11-49|101-1000|No|No|Our monitoring activities are provided by *NAME REDACTED*. The sponsor carries out a risk assessment and prepares the monitoring plan. While we work with the monitors and sites, especially in following up on monitoring, responsibility for monitoring is out with our remit.||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| 36|50+|2500+|Yes|Yes||Yes|Always|Always|The same software is used for every trial in the CTU||||||||Yes|Partial software|Yes|Yes|Yes|Yes||Yes|Yes||Yes||||||||Yes|Poor communication with site, poor data flow|No|No|If central monitoring indicates an issue with a site that may require on site monitoring , our first action is to communicate with the site. If issues can be resolved via e-mail/phone then a visit may not be necessary.|Frequently|Yes||Yes||||||||||One day|Two|Yes|Yes|Yes|Yes|Yes||||Yes|Yes|||||Yes|||Yes|||10|100|100|100|10|100|10|100|Frequently|Occasionally|Occasionally|Always|Always|Frequently|Never|Frequently|Never|What is checked, when and how frequently depend on the reason for the visit (pre-planned or triggered) and the monitoring plan which is informed by the risk assessment. For pre-planned monitoring (high risk trials) we may visit all sites at certain time points, a percentage of sites or site with X number of patients recruited. We usually check the site files (including pharmacy files), and a percentage of patient notes vs CRFs. For triggered visits we may check only a certain aspect of trial conduct at the site or we may check everything.|Stop or reduce SDV| 37|50+|101-1000|Yes|Yes||Yes|Always|Frequently|Bespoke software is written for each trial|||||||Yes|Yes|Human assessed|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|Yes|||||||Yes|Yes|Each trial has a risk assessment and a monitoring plan which are bespoke to the needs of the individual trial. These are dynamic documents and so the monitoring plan may change during the course of the trial, depending on need and any new areas of risk that arise.|Sometimes|Yes|||Yes|Yes|Yes|||||||One day|One||||Yes|Yes|Yes|Yes|Yes||Yes||Yes|||Yes||||||10|100|10|10|10|100|10|100|Always|Always|Occasionally|Always|Always|Always|Always|Always|Always|Visits usually last one day and so depending on issues raised, the agenda for the visit may change. If for example there are multiple issues with consent, the time for SDV may be limited.|Optimise central monitoring| 38|11-49|101-1000|No|Yes||Yes|Always|Sometimes|Central monitoring is not programmed||Yes|||||Yes|Yes|Human assessed||Yes||||Yes|Yes|||||Yes|Yes||||||No|Yes||Frequently|Yes|Yes||Yes|||||||||One day|Two|Yes||Yes|Yes|Yes||Yes|Yes||Yes|||||Yes||Yes||||50|100|100|100|30|100|100|30|Frequently|Occasionally|Occasionally|Always|Always|Always|Always|Always|Always||Optimise central monitoring|