YouEDC Trials

Site statuses and activation, enrolment, monitoring visits, reports and letters, action items, protocol deviations.

YouEDC Trials is the fifth section of the portal, a simple clinical trial management system (CTMS) for monitors and the project administrator. It keeps site statuses and activation, the enrolment plan and fact, monitoring visits with reports and letters to the site, action items with dates and the protocol deviations log. The sites' numbers (patients, SDV, queries, consents) come from YouEDC Capture by themselves; in a YouEDC Studio project enrolment is entered by hand.

The YouEDC Trials tab in the top bar opens the monitor's desk: what waits for you today across all your studies and a table of your sites. Inside a study the section opens from the YouEDC Trials menu item. The Portal Owner switches the function on (the “YouEDC Trials” function in Functions and limits).

Who sees what

• The project administrator and the monitor plan visits, write reports, keep sites, action items and deviations. A monitor limited to some sites sees only those sites (in the statistics, every site by name and the patients of their own sites).
• Reports are approved by the project administrator and by the members the manager marked in the section's settings (the “lead monitor” is a right, not a separate role). The author never approves their own report.
• The investigator sees their sites, the monitor's letters to their site (and confirms reading them), the action items given to the site and the site's deviations. Monitoring reports are not shown to investigators.
• The data manager sees sites, enrolment, action items and deviations, and classifies deviations.
• The viewer (sponsor) sees a summary without patient numbers; in the statistics, the patients behind the numbers only when the project administrator allows it.

Patients are written by their numbers only everywhere: no names, dates of birth or other details that identify a person. The site's source documents are not uploaded to the portal.

Sites: status and activation

On the site page choose the status and mark the activation steps: confidentiality agreement, feasibility questionnaire, selection visit, contract, ethics committee approval, the site in the authority's permission, essential documents, initiation visit, activation. Each step has a planned date, a done date and a note; the sites table shows how many steps are done and which is next. Every change goes to the audit trail.

Enrolment plan and fact

The Enrolment page compares the plan with the fact for each site and for the whole study. The plan is the site's target (set on the site card) spread evenly over the enrolment period from the section's settings, starting on the day the site was activated. In a YouEDC Capture study the fact is counted by itself from enrolled patients; in a YouEDC Studio project screening and enrolment are entered on the site page. The chart shows the cumulative fact, the plan as a dashed line and today.

Monitoring visits and the report

1. Plan the visit on the Visits page: the site, the kind (selection, initiation, routine, close-out), at the site or remote, the date and the monitor. Before the visit its page shows the preparation: the site's numbers and what is new since the last visit, the site's open action items and deviations, the questions of the coming report.
2. Mark the visit done with its dates. The site's numbers are kept in the report at this moment; while the report is a draft they can be counted again.
3. Write the report: the people met, the answers to the questions (yes, no, not applicable, with a comment), the findings for the site, the monitor's internal findings and conclusions, action items for the site with dates. Save the draft as often as you like.
4. Sign and send: enter your password. The version of the report is frozen, its hash is signed with the meaning “Author of the report”, the approvers get an e-mail.
5. The approver opens the version and signs it with their password (“Reviewed and approved”) or returns it with a note. On return the author's signature is withdrawn; the monitor corrects the report and sends a new version.

Nothing is lost without a connection. While the monitor writes the report, the draft is also kept in this browser. When the connection is lost, the form is not sent and the portal says the draft waits in the browser; when the page opens again, the text comes back into the form and only needs saving. The Discard it and show the saved report button removes the browser copy. Once the report is saved on the server, the browser copy is no longer needed and goes by itself. On a shared computer, save the draft before you leave.

The approved report goes to the TMF inbox (selection, initiation, monitoring, close-out) and each version downloads as a Word file. An approved report changes only with a reason: it becomes a draft again, and the approved version stays in force until a new one is approved. The report deadline (10 days after the visit by default) is set in the settings; late reports come first on the monitor's desk.

Letter to the site

After the approval the portal prepares the letter to the site from the report: the findings for the site and the site's open action items with dates. The monitor's internal findings and conclusions are not in it. The monitor checks the text, edits it if needed and sends it. The site's investigators get an e-mail, open the letter in the portal and press I have read the letter; the monitor sees who confirmed and when. A sent letter does not change and goes to the TMF inbox. The letter deadline (15 days after the visit by default) is set in the settings.

Action items

An action item is what has to be done, by whom (the site, the monitor, the sponsor, the data manager), by which date and how urgently. Action items are numbered in the study and linked to a site and, when they came from a visit, to that visit. The day before the date the owner gets an e-mail, and one more when the date has passed. When you close an item, write what was done. An investigator sees and closes only the items of their site.

Protocol deviations

In the deviations log each deviation has a number, a site, a patient number, a category (consent, eligibility, visit window, missed visit, investigational product, safety reporting, prohibited medication, other), the dates it happened and was found, and its source. The Find possible deviations in the data button in a YouEDC Capture study offers possible deviations: consent signed after enrolment, a visit outside its window, a visit that did not take place, and the rules the deviation plan switches on (below). Each such suggestion appears once; a person decides.

A deviation is classified as important or not important (ICH E6(R3): an important one may significantly affect the completeness, accuracy or reliability of the key data, or a patient's rights, safety or well-being) and its corrective and preventive actions are written down. A deviation closes only after it is classified.

Protocol deviation plan

The project manager, the monitors and the data managers agree in advance which deviations the study expects. The Deviation plan page (Deviations tab) keeps them as types: a code, a category, a description, the default importance, the flag may reveal the treatment and how each type is found: by people, or by a rule of YouEDC Capture with its parameters. Upload the sponsor's plan from Excel (the page gives a template with a second sheet of the allowed values) or add and change types in the portal. Every change, an import too, is a new version of the plan with its author, date and note; the audit trail lists which codes were added, changed and removed.

• Rules, not guesses. The rules are fixed and give the same result on the same data, so they can be validated (GAMP 5); there is no artificial intelligence. Besides the three rules above, the plan can switch on two more: an eligibility criterion not met for a patient who went on in the study (on the eligibility form, an inclusion criterion answered “No” or an exclusion criterion answered “Yes”, and the patient has data at another visit: a screen failure that stopped there is not a deviation; the form code and the field prefixes are parameters, IE, INC and EXC by default) and a form not filled in at a visit that took place (all forms of the visit, or the form codes listed). These two run only when the plan has a type for them.
• Classified by the plan. A possible deviation found by a rule gets the type detected by that rule: its category, default importance and blinded flag, with the plan version in the audit trail. People may change the importance; a deviation without a type is classified by people as before. When you add a deviation by hand, choose its type from the plan.
• Blinded types. A deviation of a type that may reveal the treatment (for example, a kit of another arm dispensed) is seen by the unblinded team only: blinded members do not see it in the log, the counts, the menu badge or on a form. A deviation at a form for the unblinded team is theirs only too.

Deviations in the eCRF

A deviation may have a place: the patient, the visit and its occurrence, the form and the field. On the data entry page of YouEDC Capture a field with a deviation shows a small marker with its number (red for an important one, grey once closed); it leads to the entry of the log. The Protocol deviations card next to the queries lists the deviations of the form, and the people who record deviations (the monitor, the data manager, the site, the project manager) record a new one there: choose the field (or the whole form), the type from the plan or the category, and describe it. In the log, the place of a deviation leads back to the form at that field. Possible deviations found in the data get their place too when they have one (a visit, an eligibility criterion, a missing form). The markers and the card are shown to those who see the deviations log, at their sites only, and never on a form hidden from a blinded member.

The log finalised and approved

Before the database lock the deviations log is finalised: on the Finalisation and approval page its author (the monitor, the data manager or the project manager) signs the whole log with the password, once every deviation is classified. Another person who approves visit reports approves it with their own signature or returns it with a note; the author never approves their own log. The approved version goes to the TMF inbox as a Word file (deviations for the unblinded team only are counted there, not listed, as the TMF is read by the blinded team too). Any later change of the log (a deviation added, classified or closed) makes the signed version out of date: the log page says so, and it must be signed again. A blinded member signs no log that holds deviations for the unblinded team only. The item Protocol deviations log finalised and approved of lock readiness follows it by itself.

Monitoring plan

The plan sets how often each active site is visited, by its risk level from Site risk in YouEDC Capture. The project administrator switches the plan on in the section's settings and writes the days between visits for high, medium and low risk (30, 60 and 90 by default). A site without enough data, and the sites of a YouEDC Studio project, count as medium risk.

• The next visit is due on the day of the last initiation or routine visit (or the site's activation) plus the days of its risk level. It shows in the sites table (“by the plan”) and on the site page.
• When that day has passed and no visit is planned on or before it, the site goes to the monitor's desk marked “visit” with its risk level.
• The risk level is counted again from the study's data, so when a site's risk grows, its next visit comes nearer by itself.

Risk-based SDV. In the same settings the plan sets which share of the forms that need SDV a site must have verified at each risk level (by default high 100%, medium 50%, low 20%). The share verified comes from YouEDC Capture. When a site has verified less, it shows on the site page and in the sites table, and the site goes to the monitor's desk marked “SDV”. When a site's risk grows, the share it needs grows too.

Signing the plan. The Monitoring plan tab shows the plan in force and its versions. A monitor or the project administrator writes the rest of the plan (for example remote visits and how issues are escalated) and signs a version with the password: the author's signature. Another person who approves visit reports approves it with their own signature, or returns it with a note. The author never approves their own plan. The approved version goes to the TMF inbox as a Word file. When the plan's settings are changed after the signature, the tab warns that the plan must be signed again. Every signature, return and refused signature is in the audit trail.

Statistics by site

The Statistics tab shows every site of the study side by side: enrolled against the plan for today, dropped out, open queries per patient and queries older than 14 days, SDV done, visits missed or out of their window, patients without consent or who must sign again, important deviations, adverse events per patient and the days since the last monitoring visit. The tiles on top add the study up; a click on a tile sorts the map by that indicator, the worst sites first.

• The colour compares with the study. A site is compared with the median of the sites that have at least 5 patients; counts (queries, missed visits, deviations) are compared per patient. An amber cell is 1.4 times worse than the median, a red one twice as bad or worse. A site with fewer patients is grey: with three patients one drop-out is already 33%, and a colour would mislead. For adverse events amber marks unusually few reports. The days since the monitoring visit are compared with the monitoring plan (the medium-risk days while the plan is off).
• Every number opens the patients. A click on a cell opens the site's statistics: the site against the study's median and the table of its patients with the filter already on (for example, only the patients with old queries). Above the table you see whether the number matches the data now; if something changed since, both numbers are shown. The patient's code opens their card in YouEDC Capture. The table shows 50 patients a page.
• The summary is counted in advance. The map's numbers come from a daily summary by site, so the page opens fast in a big study too. It is counted once a day and with the Count again button (project administrator, data manager, monitor; at most once in 10 minutes). A small study is counted at once when first opened, a big one in the background. The audit trail is never read for the statistics.
• Who sees what. The project administrator, data managers and monitors see every site by name, and the patients of their own sites. An investigator sees only their site against the study's median; the other sites are not named. The sponsor (viewer) sees the numbers of every site; the patients behind them only when the project administrator allows it in the section's settings, and then without opening the patient's card.
• Blinding. There is no split by treatment group in the statistics for anyone. In a blinded study the forms for the unblinded team are left out of the numbers for blinded members: the summary keeps two sets of numbers, and each reader sees the one they are allowed.

A YouEDC Studio project has no patients in the portal, so its map shows only enrolment (from the numbers entered by hand) and the days since the monitoring visit. In a demo study the statistics are ready right after it is made: the sites are activated, monitoring visits have approved reports, the possible deviations are classified, and the last site has not been visited for a long time.

Statistics across studies

The Statistics across studies tab next to the monitor's desk (also in the section's menu) puts all your studies on one page. At the top are the totals: studies and sites, patients enrolled against the target and the plan for today, sites with a red cell on the map, open queries and queries older than 14 days, SDV, late reports and how many studies will finish enrolment after the plan.

• The studies table. The enrolment bar shows the fact, the black mark the plan for today, the target is its right end. The forecast end is the date the target is reached at the rate of the last 8 weeks (of the weeks so far when enrolment began later); it is amber when it falls up to 30 days after the planned end of enrolment and red when later. Sites by colour counts the sites by their worst cell on the map: red, amber, green, grey. The sparkline is the patients enrolled over 12 weeks. A study's code opens its map of sites.
• Sites needing attention. The ten sites of all studies with red and amber cells, those with more red ones first. Each indicator opens the site's statistics with the patients filter already on.
• What changed in 7 days. A comparison with the summary of a week ago: new and dropped out patients, open and old queries, SDV, new important deviations and serious adverse events, cells that turned red and monitoring visits done. It fills once the summaries have been written for a week.
• Trends. At the bottom are 12-week charts across your studies: patients enrolled, open queries, queries older than 14 days and SDV. The same sparklines are on the project's statistics tiles and in a site's statistics, and the Enrolment tab shows the forecast on its chart.
• Home screen widget. "Studies in YouEDC Trials": the studies with their enrolment bar and red cells, and the three sites that need attention most.

Everything is read from the daily summaries: the page recounts nothing, so it stays fast with dozens of studies. A study without a summary is counted in the background and marked as being counted. Who sees what follows the project's statistics: an investigator sees only their sites, everyone else every site, and a site's statistics open only within your sites. Summaries older than 90 days are kept one a week, so 12-week trends take little room. A demo study has the summaries of every Monday of 12 weeks, so the trends and changes show at once.

Section settings

The project administrator sets the enrolment period (start and end), the report and letter deadlines in days, the monitoring plan, whether the sponsor sees the patients in the statistics, and the list of people who approve reports. The section's e-mails (a report waits for approval, a report is approved or returned, a letter to the site, an action item is due) are switched on and off in the profile.