The following entry is identical to the file attached to the question above. It contains the details that MUST be known/read by EACH RG Clinical Researcher who will answer this question:

How Can One Improve Source Document Development?

How can one improve Source Document Development? or How can one BETTER anticipate specific data to be collected on Source Documents for clinical research studies?  How can one predict what a monitor will or will not require? How can specific data collection for clinical research studies be collected more efficiently? 

Rationale for this question:

Do your source documents need continuous editing? Or revising?  in order to add more information that that the monitor is requesting over time?

Example: Let’s say Protocol 123abc states that the temperature is to be temporal, BP taken when subject is sitting down after 10 minutes or more minutes relaxation and repeated on same arm 3 minutes or more after the first reading with a required calculated average to be recorded. 

Scenario:  Current Source Document shows a space/line for the actual time BP and Temperature was taken, along with the actual measurements. 

BP: [first]     time taken _____________

BP [second] time taken _____________

Temperature time taken: ___________

Rationale:  It is understood that the protocol is being followed, as CRC has been trained with a certificate of training on file, to show that Temp & BP are actually being done & recorded/documented, and that proper devices and methods are being used per protocol.

Issue:

Monitor does not mention until the 5th subject visit [of 32 total SV’s in study] that HOW the measurement was taken must be noted in the source document.  Monitor requests  ‘Temporal Temperature’, not just ‘Temperature’ alone be added to subsequent Source documents and  ‘BP taken when subject has been  seated  for at least 10 minutes and repeated at least 3 minutes after first BP reading’,  must be noted in the Source Document not,  just BP and time taken.

Monitor does NOT accept that the Source document also shows time the subject arrived, was interviewed and vitals [Temp and BP/Pulse ] taken, and that the times recorded by the CRC show that they are at least 10 minutes, usually 15 or 20 minutes,  after arrival and at least 3 minutes apart.

Solutions to satisfy Monitor’s request:

Solution # 1: A New source document was created that satisfies request of Monitor. It now looks like this:

BP [first] :    time taken _____________                 Right arm                              Left arm

BP [second]:  time taken _____________               Right arm                              Left arm

Note:  All BP are taken with the patient seated at least 10 minutes prior to the first measurement and

At least 3 minutes prior to the second reading.

Temporal Temperature: time taken  ___________

Solution # 2 A Note to File was made to document that all previous BP measurements and temperatures were taken by the method outlined in the protocol prior to dd/mmm/yyyy  [actual date was used].

1.        BP is taken when subject has been seated  for at least 10 minutes and repeated at least 3 minutes after first BP reading’.

BP [first] :    time taken _____________              Right arm                    Left arm

BP [second]:  time taken _____________           Right arm                    Left arm

2.       All Body Temperatures were taken temporally from 'date A' to 'date B'. All future source documents will note that they are to taken temporally. Source documents previous to 'date A' will have handwritten note documenting that the "Temp was taken temporally" initialed and dated by the CRC who did the original recording of the temperature.

How do you

a) Get a monitor to let you know about these things at the very first monitor visit?

b) Make sure these things are added to the Source Documents before the first subject of the study arrives?

What is YOUR solution? What 'tricks' do you have for developing good Source Documents with good Check- Lists?

Thank you for your input in advance, 

I am interested in the various methods, check lists, "thinking", etc that clinical researchers have to make their SD's all encompassing w/o re-writing the who protocol.

Jeanetta Mastron

We develop source data collection worksheets on medical history paper prior to the start of any study - these are filed in the patients medical notes once completed at each study visit. When developing these sheets, the method we use is dependent on comprehensive the protocol is, if we have access to the eCRF/paperCRF prior to the first patient, and if the sponsor has supplied any type of source documentation themselves. We look at all of these components (the lead nurse and the site data manager) and develop a comprehensive source document which covers the needs of the protocol/eCRF and any other documentation supplied by the study. This is marked as version1. If we are monitored and changes are required/amendments require a change of data collected we update the source data sheet and version control it. Unfortunately, if the sponsor does not supply source data sheets; changes are always required to the site source data sheets at some point in the study.

Dear Clinical Researcher/RN Kathryn L. Walker; The Newcastle upon Tyne Hospitals NHS Foundation Trust,

Firstly: Thank you for taking the time to read all that I posted as the details of the question.

Secondly, I thank you for answering the question and giving the method you use. The method used where I am assisting is very similar, with the exception that we do not have site data manager per se or else I have not met him/hr.  We do have CRC's, assistants, Reg. SC, Nurse and the Doctor.

Comment:

It seems to me, in the case  that the additional information of how the temp is taken, will not affect the outcome or quality of the study data or numbers recorded, only that the method will be ensured. It will validate that the temp is not oral or rectal but rather temporal.  But stating how the BP is taken as required by the monitor one can argue that this is a method of assurance, or a quality control step, subsequently the BP numbers or data are more reliable.

I found this article to add to or confirm what you are stating about the need for a team and site data manager: Data management in clinical research: An overview

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

The problem I am having is I am taking over for someone who left abruptly and finding lots of missing logs, add ons to source docs that need to be on them, etc and the monitor is also frustrated and finding that as well, or before me. Actually some seem to be superfluous, while others necessary.

Third: I think you hit the nail on the head with the following comment: A" Unfortunately, if the sponsor does not supply source data sheets; changes are always required to the site source data sheets at some point in the study." The monitor/sponsor did not provide any source data sheets. So each time we see the monitor she adds to what is needed. This is the third visit. This study also requires many many overview logs. And we are now being asked to create them and fill them it. But there does not seem to be a mention of it in the protocol, rather it seems to be a directive from the monitor.

Question: give the above last 3 sentences above is it possible that the sponsor is just now realizing that these logs should have been discussed in the protocol, need them and are directing the monitors to have us to make them now, so that there absence will not negate the study, or is it morel likely that we are not interpreting the protocol correctly? 

Thank you in advance,

Jeanetta Mastron 

This is a situation that I have encountered on many occasions. It is highly likely that you are interpreting the protocol correctly and it is either a) the sponsor is requesting more specific data be documented in the source data (this can occur if they have recently been audited by a regulatory body) or b) the monitor is making these requests to make their monitoring a little easier. Either way, I would suggest that if specific information is now required to be written in the source documents which is not requested in the CRF it is the responsibility of the sponsor to supply these source document worksheets/logs templates. It is highly unreasonable of them to expect the site to develop these documents - this type of logs should be standardised across all study sites. If the sponsor requires sites to document this information for study data analysis an amendment should be submitted - sites are not required to supply any information which is not protocol mandated. Hope this helps, K

YES, Kathryn! This helps tremendously!

It definitely validates what I, and the CRC's are thinking.

I am not sure how to go about communicating this to the monitor without her being offended. But I do agree with you, this should be done by the sponsor if it is an 'after thought' and therefore an amendment and of course should have been done if part of the protocol. And if it is to make the monitor's work a little easier that is just not right. I wouldn't mind so much if that is the case and the monitor asked for our help.  I am having to go to 3 to 5 different forms to find the information.

All in all once I get them all on track it will be more daily work, but at least I will not be playing 'catch up'. 

You are right all arms, sites etc of same study should have the same format for the logs. 

Hm...maybe it is time to speak to the PI ...what do you think? Any suggestions for handling the monitor?

Jeanetta

The PI should probably be made aware, however it all depends on how "hands on" they are with the day to day running of the study as to how they will handle it - it may be that they expect the staff on the ground to handle situations like this. I always think it is best to be honest regarding things like this and just speak to the study monitor, explaining the situation as we discussed above - as long as the monitor knows the reasons behind the request; costing of time, protocol mandated data collection, standardisation of documents across all study sites, there is no reason for them to get offended by the situation. Good luck! 

Thank you for your great advice.

Jeanetta

Dear Jeanetta,

I agree with everything Mrs. Walker mentioned, it has very often been the same situation with our studies. If the sponsor doesn't supply standardized protocols prior to the start of a study or/and some findings during the starting period of the study afford further action, it is normal that some adds or changes in the documantation are necessary evey now and then. But this needs to be documented in the appropriate SOP with mentioning of the date of the change/add and reason why the change was necessary and who requested it. Besides it is very time consuming to arrange and discuss all terms with the sponsor prior to the start of a study.

If some data is missing in the previous documentation of a dropped out team member, you should report it to the sponsor/director of study very soon and honestly, because normally there is no possibility to complete it afterwards. Besides: Everyone must sign the data that is documented, so it will be evident it was not your fault if some checking points are missing.

For fast documentation of times there is the possibility to take a photo of the fill in form and an accurate watch directly thereupon with a small camera which is just reserved for documenting time or working procedures. If you save the photos on the computer,  you name them with the date/time/name of the patient and/or study group. It's very effective for an accurate recording of times. The only thing you need to mind is to save backup copies of the photos and data every week so nothing gets lost.

Furthermore good luck with your study!

Respectfully,

Irmhild Rueter