PITCHES FAQ’s Draft document Sue and Amanda
FAQ’s
Screening and Eligibility
Q. Should we enter data women on the screening log for women whoif they do not meet the eligibility criteria ie (pruritis and raised bile acids) but we dideven though we did screen them?
A. If they do not meet the eligibility criteria, ie pruritis and raised bile acids you do notyou should not enter their data onto the screening log. screen them.It may be that she has pruritis and normal bile acids and there is a potential that her bile acids raise and become eligible so you could always screen and where eligible you enter no and then under other indicate bile acids normal.
Q. A woman is currently having acupuncture to help her with her cholestasis/itching???. Is she eligibile to participate and can she continue having acupuncture?Can she continue this and be a part of the study?
A.Yes.she can have acupuncture
IMP
Q. We have a woman participant who is already taking URSO 1g at night rather than 500mg BD because she is very nauseous in the morning when taking divided doses– is this okay as it states in protocol 500mg BD?
A. Yes this is okay as some women do like to take their tablets together in the evening.
Q. A patient participantwho is in the trial has come to clinic this week and reports that her itchhas become worseis worsening. She is currently takingon 500mg of IMP twice a day. Should she and the doctor is wondering whether the patient should discontinue taking the IMP?. Is this what we should do?
A. Rather than discontinue the IMP, consider increasing her dosage. it is suggested that the doctor increases the IMP dose as they would if the patient was on ‘open label’ UDCA
Q. A participant has suffered a bout of sickness woman was sick 3 times at clinic and sent home. She hadalthough she has been taking URSO trial medication for some time. so the sickness wasn’t considered connected to the treatment. She discontinued didn’t take taking URSO for trial medication for 2 days – should this be recorded somewhere on the database?
A. No it doesn’t need to be recorded and it is not an SAE. As The participant will be asked we will be asking the woman what what percentage of IMP she hasd taken since her last visit when she attends her next follow up visit and, this data will be collected on the eCRF.
Q. All potential participants are prescribed Vitamin K at our hospital, will they still be eligible?– is there any problem with that?
A. No, this is not a problem. These patients are still eligible for PITCHES.
Q. Sometimes multiple blood tests are taken in a period of one week. Which set of results need to be entered onto the database.
A. You should record the results closest to the weekly visits
Q. Can you take consent on a different date in advance of the randomisation date and is there a timescale on this?
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A. We would not encourage this. – It is more sensible to take consent and randomise on the same day.
CTGs
Q. As CTGs are not routinely undertaken unless clinically indicated in our hospital, is it still okay for patients to participate in PITCHES or do we have to perform one if the patient wishes to join the trial?
A. It is okay that a CTG is not performed. – dYes, do not do one justperform one just for the trial (please tick not recorded on the first antenatal visit page). As NICE guidelines state that CTG’s should be performed from 28 weeks gestation, it is possible that patients with ICP may present before 28 weeks and therefore do not meet the CTG criteria.
Bile Acid Results:
Q. We do not take bBloods are not taken routinely for bile acids after diagnosis (just LFT’s) – is this okay?
A. Yes, as long as they are available for diagnosis.
Q. Do we have to use the BA result taken on day of randomisation, rather than one that was taken days earlier?
A. You can accept eligibility on the most recent BA taken and do NOT require a repeat on the day of review. Obviously if you are in any doubt about the diagnosis and her BA is only borderline then you may want to review the diagnosis of ICP.
Q. If the bile acid result is on the limit set by the our site rather than above it, is the woman eligible?
A. If the clinician would treat the woman with URSO then she is eligible.
Q. Can a woman be randomised to the trial if she is already on UDCA?
A. Yes,a woman can be randomised to PITCHES. There there is no ‘wash out’ period as the woman has already been taking UDCA and she will be either randomised to the same or placebo. She should however discontinue taking her prescribed UDCA prior to randomisation.
Q. If a participant has had LFT’s taken but not BA’s at visits following randomisation,should the LFT’s be recorded?
A. If the patient participant has had BA taken weekly, with LFTs alongside, then this is sufficient. It is not necessary to add more LFT’s to the eCRF.
Q. A woman has weekly positive anti-nuclear antibodies, is she eligible?
A. Yes she is – PITCHES wanted to make the trial inclusive of everyone (within reason) so this is fine.
Q.Should Bile Acid results be recorded to a decimal place as the database does not currently allow us to enter a decimal place?
A. As the database does not allow for decimal points please round up or down as appropriate.
Adverse Events /Serious Adverse Events
Q. Should a PPH of 850mls be recorded as an adverse event? Our first participant in the PITCHES study delivered early at 35+3 weeks and experienced a PPH of 850mls. This event did not result in prolonged hospitalisation. Should such occurrences be recorded as AE’s?
A.A PPH is not an unexpected occurrence and it is not listed as an expected adverse event. However, if no prolonged hospitalisation then it does not need to be recorded. We are collecting and categorising estimated blood loss on the maternal delivery eCRF.EBL on the medscinet database.
Q. A woman attended the ward for a CTG as she had decreased fetal movements –she was not admitted. Does this need to be recorded as an AE?
A. No as this is an expected Adverse Event.
Pharmacy Questions:
Q. Under Drug Interactions in the training slides it states that some brands of Gaviscon contain aluminium hydroxide – Do you have a list of those, if any, that do?
A.The BNF only lists Gaviscon formulations that do NOT have aluminium hydroxide but there appears that there may be a GSK formulation of chewable tablets that contains it – it is considered unlikely that these will cause problems.
Q. Under Drug Interactions in the training slides it states that if the patient is on cholestyramine they should take it 2 hours before or 2 hours after the IMP. However, the BNF recommends that other medication should not be taken until 4-6 hours after cholestyramine (i.e. it would need to be taken 4-6 hours before not 2 hours before the IMP), can you confirm that the information in the training slides is correct?
A.We do not expect any women in the UK to be prescribed cholestyramine – this treatment is no longer used for ICP. The plan is to remove this information from the training slides in due course[AS1]
Q. On the drug accountability log, can you confirm who would should complete the ‘Verified by’ section on the log? Is this for a monitor to complete or is it part of the returns check?
A. This should be completed by aA suitably qualified member of the clinical trial staff in pharmacy who would normally undertake verification
Q. Does the PITCHES IMP bottle have child resistant closures (lids)?
A. Yes, PITCHES IMP bottles have child resistant lids.
Q. Can we use our own drug accountability log?
A. It may be possible to use your own accountability logYes but thisit must be checked by the PITCHES team to ensure that it meets sponsor requirements.
Q. One of our Pharmacists has requested aCan you provide us with a TSE Certificate in relation to the PITCHES IMP? – Is this something that you could provide us with?
A. A TSC Certificate can be provided. Please contact the PITCHES trial co-ordinator.
Q. Is it a requirement for pharmacy team members dispensing/checking dispensing for PITCHES to have GCP training?
A. Guidance around who must receive and the frequency of updating GCP training is not entirely clear. It depends on your clinical trial office who will outline the requirement for GCP training for staff, so as long as staff are working in line with their local GCP procedures this is acceptable. – Not sure about this – Sponsor requirement????
Q. What are the dimensions of the boxes containing the IMP?
A. Each container is approx 8cm x 4.5cm x 4.5cm. So a delivery containing 20 of those would be about 20cm x 25cm x 25cm depending on how they were stacked.
Database Questions:
Q. Can I change data on a form that has been saved?
A. Yes, you will need to complete thea comment box that will open asking you to explain why the data has been changed.
Q. How do we record women that are screened for PITCHES?
A. Upload Complete the Screening Log eCRF on the trial database.all patients that are screened onto the medscinet database on the screening eCRF
Q. Should we be completing a local PITCHES proforma / workbook/ or a paper CRF?
A. There are no specific workbooks to complete. Some sites may have opted to print out the eCRF’s so they have a paper version but tThe MPITCHES trial edscinet database has been designedis designed to help eliminate ‘paper trails’, therefore it is advised to upload data directly onto the database.
Q. How will I know if there have been any queries raised on the data that has been entered?
A. You will receive email notification. When data queries are raised an email will be sent to the site to advise that there is/are data query/ies to be answered. Please check the MedSciNet database on a regular basis as dData queries will also be highlighted on the eCRF pages of the participant. Queries will be highlighted on the database by a smallred ‘Q’ icon. If you click on the icon it will open the query up in a ‘query box’.
Q. Is it necessary for each woman to have her antenatal follow-up visits exactly one week apart from randomisation?
A. Sites should follow their normal normal routine practice but should ensure. and it does NOT have to be exactly at one week but rather to fit in around usual practice.Women are usually seen in about 1-2 weeks and thethat the participant woman should havehas sufficient enough tablets until her next visit.for 16 days at the usual dose of 500mg BD.
Q. What happens if a patient does not attend her clinic appointment?
A. Contact the participant to ensure that she has not run out of the trial medication. Arrange a further appointment for her if she has not already delivered. Continue with antenatal visits as the protocol states.
Q. What is the process for completing the Visit eCRFs if a participant is seen more than once a week and may have had bloods taken just on one visit?in terms of completing the “Visit” / “add new visit” eCRF?
A. It would be sensible to rRecord the visit that was nearest to the day of 7 days from randomisation day.eg if she was randomised on a Monday and the following week was seen on the Monday and again on the Thursday, record the visit for the Monday. However, if she had blood tests performed on the Thursday then record that visit.See protocol Item 9.4 Subsequent Visits on page 23 for further information.
Discontinuation/Withdrawal
Q. A participant,or her clinician has decided to discontinue the intervention, what do I need to do?
A. You will need to completeCompletethe paper copy of the ‘Discontinuation of Intervention Form’, file a copy in herthe participants notes, one in ther data file and send a copy sent to the PITCHES office. Enter “medication stopped” on the Visit eCRF.
On the database you need to put that trial medicines have been stopped.
Q. If a discontinuation form has been completed do we still need to record antenatal visits?
A. No, once a woman has discontinued the intervention you do not have to record any further visits but you should still record maternal outcome and delivery and infant outcome and delivery.
Q. Do I have to gain consent to collect maternal and infant outcome if a woman has discontinued the trial intervention?
A. No not if the woman has discontinued the intervention, her original consent is still valid.
Q. What do I do if a participant has discontinued the intervention andshe says that she does not wants no any further data collected or any data we have already collected used?
A. You would need to cComplete a ‘Trial Withdrawal Form’, file a copy in: her notes, data file and send a copy to the PITCHES office.
Q. Do we have to record any Adverse Events or Serious Adverse Events for participants that have discontinued?
A. No, after a participant discontinues the intervention you do not record these.
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[AS1]I’m not sure if it is worth including these pharmacy questions – let’s see what Lucy thinks.