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CONTACT

TRIAL DELIVERY -  PERSONNEL  

SITE IDENTIFICATION   

PROTOCOL  

CONSENT  

CONTRACTING   

DATABASE, RECRUITMENT, AND RANDOMISATION   

TRANSFER OF CARE

FOLLOW-UP AND ADVERSE EVENTS

DOCUMENTATION    

 

CONTACT

How can I contact the RECOVERY Trial Team?

The RECOVERY Trial Team’s email address is recoverytrial@ndph.ox.ac.uk.

What is the web address for the trial site?

www.recoverytrial.net

trial DELIVERY -  PERSONNEL

Who can act as a PI for the RECOVERY Trial?

The Trial Team confirmed that any adequately qualified member of trust staff (e.g. a consultant) could act as a PI and that PIs from acute trusts can act for other sites locally.

Does the PI need to provide GCP certification and a CV?

There is no need for the PI to provide a CV and GCP certificate.

I anticipate looking after many of the COVID patients in ICU. If I am PI does that mean I can’t approach for consent? If so, should I invite someone else to be PI?

The PI should not act as the legal representative, but could take consent from another legal rep (eg family member). Another doctor (independent of the trial) could act as the legal representative if no family member is available.

Who can deliver the treatment as required by the trial protocol?

While treatment will need to be prescribed by a doctor (or other suitably qualified prescriber), and either a doctor or a research nurse (or other suitably qualified member of staff) will need to seek consent from the patient, data capture (online form) can be undertaken by staff who are not clinically qualified (e.g. medical students).

Can patients who are consented to RECOVERY be consented to other (non CTIMP) COVID-19 studies?

Yes. They can also enter other CTIMPs assuming the protocols do not conflict. For example, patients in RECOVERY can enter REMAP-CAP as long as their allocation in RECOVERY in continued on ICU (eg, if assigned lopinavir-ritonavir in RECOVERY, they are not randomised in the antiviral domain in REMAP-CAP).

‘The hospital clinicians are responsible for administration of the allocated treatment.’ Does ‘clinician’ apply to all NMC/GMC registrants?

Yes: the IMPs do not have to be given by doctors.

Can junior doctors prescribe as part of this protocol?

Yes; any doctor with a prescribing licence may prescribe.

Will trial team training be a telephone SIV or in the interests of time will we be provided with PowerPoint slides?

All training is on the trial website (www.recoverytrial.net) and is self directed. When the training has been completed, the trial teams will receive their access to the online data collection systems.

Are Co-Investigators permitted on this trial to spread workload?

Yes - we welcome co-investigators at participating centres.

Does the PI need to be a member of the Infectious Diseases staff?

PIs may be staff working in a number of disciplines, including infectious diseases, respiratory disease, and ICUs.

SITE IDENTIFICATION

What type of Trust are you looking to involve in the RECOVERY Trial?

Acute trusts should be recruited as a priority; Other sites can be put on stand-by.

 

Will sites other than those with large infectious disease units be considered?

Yes; an amendment is soon to be approved allowing all sites automatic approvals to take part in this trial.

Who decides when recruitment can begin at participating centres?

Capacity and capability is to be decided by the individual Trusts. An email is all that is required to advise of this. A signed contract (or email from the signatory) is also required.

PROTOCOL

Treatment is for 10 days or until discharge - could treatment continue for longer than 10 days if the patient is not discharged in this time?

Treatment should stop at discharge or 10 days after randomisation (whichever is sooner). Continuation beyond this would be outside the trial, but the managing doctor would be free to do what they think is best. 

Does the RECOVERY Trial require any sampling?

No. The trial was designed not to be resource intensive and to be as close to routine practice as possible: i.e. the patient would be seen, data would be entered into the system and a prescription returned.

Whose responsibility will it be to undertake the follow up post randomisation?

There is a single follow up form to be completed, and this will be through Open Clinica. The PIs will confirm the staff who will be completing this, and the trial team will provide sites with this information.

CONSENT

Who can receive informed consent in the RECOVERY trial?

Any site staff who the principal investigator is satisfied has the necessary training and experience may receive informed consent as long as they have also completed the trial-specific consent training (available on the training page) and completed a “confirmation of training” form to that effect. From the trial’s perspective, GCP training is not required.

Is verbal consent from a NOK over the phone permitted, as hospital visiting is limited?

In cases such as these, legal representative consent can be used instead of that from the NOK (for example, consent from an independent doctor).

Is there any scope to include consent waivers for this trial?

Consent waivers are not possible for the trial.

How should consent for the RECOVERY Trial be obtained?

Consent should be obtained from the patient face-to-face, if the patient is well enough to provide consent.

A witness can sign for a patient who is able to review but not sign (this may be relevant where paperwork cannot be taken out of an isolation room).

For patients who are too unwell to consent there is the option of consent being secured from their legal representative.

If a patient is too unwell to consent and no legal representative is available the patient can be entered into the Study and consent obtained as soon as possible thereafter (see Protocol for further details).

If paper versions cannot be stored in the patient notes for infection control reasons, please try to capture an image which can be stored in the electronic health record.

 

Who should have the consent form (or a scanned copy)?

1 for participant 

1 for local site file (e-mail to your local lead PI or designated local staff) 

1 for medical notes (or scan into EHR)

We cannot take paper out of rooms in which patients with COVID-19 are quarantined - how should we proceed?

The following procedure has NHSE approval (Linda Dempster, Head of Infection Control)

  • The consent form remains with the individual obtaining the consent and not placed/left in the patient's immediate environment
  • The patient’s hands are decontaminated with soap and water or with alcohol hand wash
  • The patient signs the consent form with a pen
  • The signed paper consent form may leave the room without need for additional decontamination
  • The pen stays with the patient or is cleaned before leaving the room.
  • The person taking consent follows all other IPC guidance as instructed by Trust

If this is not accepted by the trust infection control policy then either place in a ‘polypocket’ and clean (and remove from the room the next day), if this is acceptable, or get an image and transfer to the electronic record (or print for notes) as long as this complies with local Information Governance policies.

Should patients only be recruited from infectious disease units?

Patients eligible for the RECOVERY Trial are likely to enter secondary and tertiary care via many avenues and patients may be recruited regardless of their point of admission.

Why are you collecting name, date of birth and NHS number? 

This is to allow linkage with NHS Digital (and similar bodies) to collect real-time information on progress to supplement the follow-up form data (and to provide longer-term followup).

What do we do if a participant who entered the trial on the basis of consent from a legal representative regains capacity and declines consent for the trial?

If they have not completed their medication and refuse to do so, then please stop it. Please discuss whether they would be willing to allow the follow-up form to be completed, but if they refuse permission for this too ask about registry-based follow-up. Please email recoverytrial@ndph.ox.ac.uk with their study ID and their final decision.

CONTRACTING

Can we negotiate terms of this contract? 

No. This is the model non-commercial agreement and there is no capacity to negotiate. 

Are there any payments associated with this trial?

No (beyond the portfolio support)

Are any ETCs associated with this trial? Is there a SoeCAT that can be shared?

There and no ETCs for the trial. The SoECAT is included in the Local Information Pack.

Will sites have contract recruitment targets?

No.

Does the contract need to be signed, or is there an assumption that the contract is agreed when C&C is issued?

Ideally yes, but if this is not possible, then an email from the signatory will suffice.

The contract is a PDF; is a word document version required for signature?

Please print off the signature page, wet-ink sign it, scan it, and return it to the trial team.

DATABASE, RECRUITMENT, AND RANDOMISATION

Should recruitment data for the RECOVERY Trial be uploaded to LPMS?

No; the RECOVERY trial will have a manual upload route, and all recruitment information will be provided by the central Trial team.

Is there a paper CRF, or should data be added straight to the database?

There is no paper CRF and all data entry should be done directly online. Examples of the CRFs are available on the website. 

What is the process for issuing usernames and passwords for the randomisation server?

Site teams do not need to know their username as the system pre-populates this for them once they select their site name.

Will team members have their own randomisation server log-ins?

Randomisation passwords are provided to each site, not individual.

 

Is recruitment time limited? E.g. within 24 hours of a positive result?

No, recruitment is not time limited, but we would not recommend randomising a patient who is already getting better.

transfer of care 

Participants may be transferred to a different hospital during their care for Covid-19.

What should I do if a participant is transferred to another hospital?

During the course of their care, RECOVERY participants may be transferred from one hospital to another for various reasons:

  •  “Step-up” transfers e.g. for ventilation or ECMO as the original hospital cannot offer such interventions.
  •  “Step-across” transfers e.g. to re-distribute patient numbers, some patients may be moved from one location to another (perhaps to a Nightingale hospital) to relieve pressure on the original hospital.
  • “Step-down” transfers e.g. for rehabilitation once the acute phase of treatment is over.

Step-down transfers

For the purposes of RECOVERY, step-down transfers would be considered discharge from acute care so the study treatment should be stopped on transfer and the trial’s Follow-up form can be completed at the time of transfer.

Step-up or step-across transfers

By contrast, step-up or step-across transfers would be considered ongoing acute care which raises a number of trial-related issues. Any receiving hospital of such patients will also be a RECOVERY site (as the trial has agreements with every acute NHS trust/health board in the UK and HRA approval for the same).

The issues to consider are:

1. Communication
It is essential that the sending hospital inform the receiving hospital that the patient is participating in RECOVERY, when they were randomised and their treatment allocation. This can be done by printing the Randomisation summary from the trial’s web-based Randomisation system and sending it with the participant.

2. Treatment
All study treatments are given on a standard doctor’s prescription in RECOVERY so any remaining course should be prescribed by a doctor at the receiving hospital. If the sending hospital has ‘packed down’ a treatment course for the participant, this may be transferred with them (like their usual medication). If treatment is not available at the receiving hospital then it will have to be withheld until this can be rectified.

3. Consent
If a participant who was consented using a legal representative at the admitting hospital later regains capacity at the receiving hospital where they are still receiving acute care, then trial staff at the receiving hospital should endeavour to obtain written informed consent from the participant. A copy of this consent form should be sent securely (eg, sending a scanned copy using NHSmail) to the admitting hospital for them to keep in their site file.

4. Second randomisation
It is not possible for a participant who has been transferred to be randomised into the second randomisation at a hospital different to their admitting hospital.

5. Investigator oversight
The receiving hospital will have a Principal Investigator who will undertake to oversee the trial for all trial participants at their site (regardless of where they were randomised). If this PI holds a contract with the sending hospital then they can be considered a sub-investigator at the sending hospital as well, but this is not essential. This includes being responsible for assessing any possible study-treatment related serious adverse events and ensuring they are reported to the sponsor in a timely fashion.

6. Follow-up data collection
The Follow-up form will have to be completed by staff from the sending hospital (as they will have access to the participant’s record on the OpenClinica system). It is not possible to grant staff at the receiving hospital access to the OpenClinica database for the sending hospital (as it contains data on many participants not under their care), so it is therefore vital that they establish a connection with a link person(s) at the receiving hospital who they can contact when the 28 day Follow-up form is due. It is suggested that the Follow-up form is completed by staff at the sending hospital while speaking to their link person at the receiving hospital on the phone who can provide the limited details required (medication, ventilatory and renal support received during the hospitalisation and date of discharge or death).

FOLLOW-UP AND ADVERSE EVENTS

When should a Follow-up form be completed?

 

Please complete a Follow-up form at the EARLIEST of the participant’s discharge, death or reaching 28 days after randomisation.
Who can complete a Follow-up form? A group of people have been nominated for each site and given access to the OpenClinica system on which these forms are completed. If other people need access, please contact the trial team via email.
What is the Follow-up form collecting? The form collects simple information on medication received during the hospitalisation, dates of discharge (or death), use of ventilation and renal replacement therapy. An example form can be downloaded from the Follow-up page.
How do I record the drugs?

We would like you to indicate if the participant received any of the drugs listed on the form after they were randomised (regardless of whether it was their trial allocation or not). If you indicate a drug was given, then you will be asked to enter how many days they took it for during the 10 day period after randomisation. If they take any dose on any day, that day would count.

What if a participant wants to withdraw from the trial? 'Withdrawal' means different things to different people. Participants may wish to discontinue their study treatment (or their doctors may wish them) which can be done without withdrawing any consent. They may decline to provide information for the Follow-up form, but we would still like to collect information from NHS registries. They can withdraw consent for that too, but this would be unusual. If a participant does wish to withdraw from follow-up in some way, please email the trial team.
What adverse events need to be recorded? The trial protocol specifies that adverse events only need to be recorded if they are BOTH (i) serious; and (ii) believed – with reasonable probability – to be related to study treatment. Other adverse events do not need to be recorded.
What is considered a 'serious' adverse event? Serious Adverse Events are defined as those adverse events that result in death; are life-threatening; require in-patient hospitalisation or prolongation of existing hospitalisation; result in persistent or significant disability or incapacity; result in congenital anomaly or birth defect; or are important medical events in the opinion of the responsible investigator (that is, not life-threatening or resulting in hospitalisation, but may jeopardise the participant or require intervention to prevent one or other of the outcomes listed above). As all RECOVERY participants are already in hospital, the major criteria to consider are whether the event prolongs admission or requires intervention to prevent something worse happening. Known side-effects of the treatments (e.g. QTc prolongation with hydroxychloroquine, diarrhoea with lopinavir-ritonavir) are not necessarily serious unless they require significant intervention (e.g,.more than just stopping the medication) or prolong the hospitalisation.
How should we assess 'relatedness'? The key phrase is “with reasonable probability”: there needs to be some evidence that the drug caused the event (not that this can necessarily be known for sure). It is not correct to report an SAE as related just because a relationship cannot be excluded.
Do re-admissions need to be reported as SAEs? Re-admissions only need to be reported if they are thought to be probably related to study treatment. We will capture readmission information through our linkage with NHS Digital so this information will not be missed.

DOCUMENTATION

Where can I obtain all of the documentation required for the RECOVERY trial?

All documents relating to the trial will be placed on the trial website at http://www.recoverytrial.net which is intended to be a single point of access for everything.

What contracting requirements does the RECOVERY Trial have?

The Study Information Pack contains an agreement signed by Oxford, which should be signed and returned to the Study Team. There is no capacity for renegotiation and no OID is needed.

Will the RECOVERY Trial require an ISF to be sent to each site?

No, the only documentation generated by the trial as investigator site files are consent forms which should be scanned and submitted electronically, with originals kept on site.

Do PIS/ICF and other associated documents require localisation?

We do not wish you to localise because we will maintain version control through our website.

 

Will a delegation log be made available for use by the site team?

No delegation log required.

Would it be possible for the PIS and ICF to be provided in other languages?

There are a limited number of translations of the PIS and ICF on the Randomisation page.  If the translation you need is not available and the patient is unable to speak English, an English-speaking family member, or legal representative, may be engaged to obtain consent.

 

 

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