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Saturday, January 29, 2011

Perfect Clinical Trial Source Documents

As a CRA, I regularly visit the sites to review the study conduct, encourage study participant recruitment, evaluate the ongoing suitability of the investigative site, provide protocol specific training, track investigative supplies, and to review source documents.  Source documents are the roadmap and clinical record to let me (or anyone who is reviewing) know what happened, when, how, and by whom.  When I look through source documents I am checking that they follow the principle of ALCOA:

  • A-attributable, who wrote this?
  • L-legible, can I read this?
  • C-contemporaneous, was this recorded at the time of trial conduct or later?
  • O-original, is this unaltered or copied?
  • A-accurate, is this a correct reflection of the conduct?
The burden for documentation in a clinical trial is actually much higher than the burden for documentation in a standard clinical record or office/physician visit.  When you see your doctor for a flu he might write 3-4 lines in your chart documenting the visit.  If you were a clinical trial participant, the doctor or the clinical trial staff would likely need to collect and record a lot of specific information to satisfy the data collection requirements of the trial.

It is never acceptable to use
correction fluid in source documents.
The first time the pen touches the paper to record observations in a trial, this generates "source documents".  If the nurse writes your blood pressure on her hand, her hand is a source document. If you stand on the scale and your weight is recorded on a post-it, that is a source document.  One of the most important rules of GCP is that the Principal Investigator (PI) is ultimately responsible to ensure that all source documents are maintained in their original form and that any alterations or corrections are indicated in a compliant fashion (changes should be striken through with a single line (so as not to obscure the orignal entry); correction fluid should never be used! The revision should be initialed and dated so there is a record of who made the change and when. An explanation of the change is optional but best practice).  The PI should instruct his staff not to write on their hands or sticky notes, to make observations using indelible ink (not pencil since that can be erased!) and to always observe the ALCOA principle when generating or modifying source documents.

Some sponsors actually provide source documents to the investigators to assist them to record all the required data during the study visits.  The source templates will typically have a blank header to record the subject identifying information and to indicate the date of the visit. Quality source will also include signature or initial blocks on each page so that the person(s) completing the forms can be identified later. If source documents are complete and accurate, the clinical trial data can be copied over and provided to the sponsor on Case Report Forms for analysis. I'll provide an introduction to data capture/EDC and analysis in a future blog topic.

During source document review I always find items that are incomplete (left blank), inaccurate (such as blood pressures that are inconsistent with life, headers that indicate a different patient entirely, birth-dates that don't match the age, units or counts that aren't possible), or otherwise erroneous source.  I use small colored post-it notes (stickies) to flag my findings and ask the PI or the study nurse to review and update the source with notation.  I never "fix" the source myself.  If the source errors are very wide in scope, I will note it in my monitoring report and I may also ask the investigator to generate a signed and dated Note to File on the site letterhead explaining what happened with the source documents and the corrections completed during our visit.  Experienced study coordinators and investigators will not be surprised or frustrated when I request source corrections or clarifications.  Also, discovering errors in the source does not upset me at all, this is part of my job and I am partnering with the site to help them keep their documentation totally complete and an accurate reflection of what was done.

Source documents are created during the patient visit and should not be fabricated a few days before a monitoring visit.
Do I want to see perfect source at my visits?  Actually, absolutely not.  Original source documents will be working documents and I am expecting source documents to be a bit tattered, thumbed through with bent corners, covered in the occasional stain, marked with revisions, and otherwise imperfect.  Perfect source or typed source makes me especially suspicious and can be an indicator of fraudulent or sloppy record keeping.  I hope this discussion is helpful to you and that you will know what to look for when reviewing source documents at your monitoring visits.

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Anonymous said...

Hi, some sponsors don't allow investigators to use source data worksheets/templates arguing that source data should not contain instructions nor any other items (logo, etc.) which would not usually appear on a patient medical file.
Is there any legislation which confirms this audit finding?
Thank you

Nadia said...

Hi thanks for a great question that I adapted into a new post. I hope I address your question fully in Q&A: Sponsor Furnished Source Documents.

Anonymous said...


I just wanted to say that I really appreciate you doing this blog; I am new to the field of clinical research and reading your blog's has been so helpful!

Thanks again!

Anonymous said...

So happy I found this blog! One question, as a CRA, would you be concerned if source data was being recorded in a word document on a desktop computer by the Study Coordinator, then later printed out for PI signature. There is no indication of who "entered" the information onto the word document, i.e. no signature of the SC.

Anonymous said...

So glad I found this site/blog....I am presently interning with a Clinical Research Training Institute online, and this is a very resourceful tool. Thank you so much!

Anonymous said...

Could you please tell me what is your opinion about creating source documents for clinical trials and keeping it separate from the usual practice medical records. For example some investigators prefer to separate patient that participate in the trial from the "regular patients" and they like to have different form of source documents, also some of them use different software for keeping medical records but when they participate in clinical trials they want to have paper source documents for patients in clinical trials and they do not want to use usual software for recording trials visits. What do you think about this? Is it mandatory to have the same type of source documents for patients in clinical trial as medical records in standard practice? In GCP it is stated only that SD needs to be ALCOA but no words about this…..

Anonymous said...

I have a question, If site has provided with source document template where everything is captured in the form of checklist as per the protocol, FOR ICF administration I found site has their sop for reference. time of consent, date of consent, duration of consent who was present during the consent process, description of what was administered to the subject is not available. But at site, their sop is is clearly specified what is the discussion about all aspect of the trial and ICH. Clearly written what was explained to the subject and if subject has any question it can be provided with answers of subject queries.Will the SOp is sufficient to refer in such case?

NadiaBoBadia said...

Hi and thanks for requesting my input on site-specific subject consenting SOPs and checklists. I am very familiar with these tools as there is a trend now at study sites to use them. It is a good practice to have these items but it is more ideal to have hand-written notes explaining the consent process. It could be as simple as stating "Subject was consented in accordance with site SOP." As monitors, we need to remind PIs of their regulatory responsibility to properly consent and we have to review every subject's consent to be satisfied that this was done. Ultimately however, it is the PIs responsibility to ensure that proper consenting takes place. In an audit situation, they would have to defend their SOP so remind them of that. I hope that addressed your question. Here is another post you might enjoy: link to Sponsor Furnished Source Docs.

Anonymous said...

I am unable to find anything in ICH/GCP or FDA regs that REQUIRE progress notes for study visits. I also know of several hospital research centers that do not use progress notes. Is there any regulation or guidance you know of that addresses the use of progress notes?

Anonymous said...

A patient was included in a clinical trial belonging to Sponsor "Y" but he also was included (time ago) in a different trial belonging to Sponsor "X". The clinical trial from the Sponsor "X" is over and the file with the medical history of the subject also contains information about the trial from sponsor "X". What's the best way to proceed from Sponsor "Y", to verify medical history and all relevant information of the subject in this file that contains information from a different sponsor?

I'll really appreciate your comments

sabeena said...

Perfect Clinical Trial Source Documents article is really helpful for new ones in clinical research field.

Anonymous said...

I am wondering if you have sample worksheets monitors can use during SDV on site as this will also help capture everything the site might be missing

NadiaBoBadia said...

Thanks for a great blog topic suggestion. Please check out my Feb-2012 post about the monitoring tools & notes I like to use during SDV.

Anonymous said...

I came across your blog while Googling a particular question I have that I cannot seem to find any guidance on. Maybe you can shed some light. I'm the Study Manager for our site which is part of a larger medical practice. Our physicians use iPads or laptop to enter patient information into the practice's EMR system. Our research side is "separate" in that we don't utilize the EMR system to log subject information; we use paper forms because - overall - we find it's easier for monitors to review (or at least that's the feedback we get). However, I'm looking at streamlining the research subject experience by reducing unnecessary paperwork for the CRCs and am exploring the use of electronic source for study subjects that would be generated into a hard copy for the subject's source chart. Specifically, we would use an editable form that could be accessed via an iPad or laptop, fill-out during the visit and then simply printed. This printed copy would become the original and any corrections would be made on the paper itself (audit trail). We've discussed this as a practice and as it stands everyone is in favor of this because walking into an exam room with a study patient, being able to whip out an iPad and enter data on the fly that is then printed at the end of the visit and put in the source char is much easier than juggling (at times) a lot of paperwork. We've spoken with some sponsors who haven't said yes or no and the FDA's guidelines are not exactly clear. My understanding is that when it comes down to it source is whatever the site uses - as you said, even a Post-It can be source - and since most sponsors leave source creation up the site I gather we can use this type of electronic source as long as it shows the date, time and person creating it. What are your thoughts? I'd be interested in hearing your take.

Anonymous said...

Perhaps you can shed some light on an issue at our site. I'm the Research Practice Manager for a research site affiliated with a much larger medical practice. Our physicians use either iPads or laptops to access the practice's EMR system when meeting with their patients. Our research side still uses paper source documents because, overall, we find it easier to provide monitors paper charts of study-related subject source with access to the EMR system to cross reference. Plus, our EMR system won't allow us to create modules for research. In an effort to streamline our research practice and improve the quality of subject source we're exploring the use of editable source forms (ie, visit 1 source) that can be accessed on an iPad or laptop, have the visit data entered directly into the form and then printed off and placed in the subject's source chart. Future changes or corrections would then be made directly on the paper form (audit trail). We did some test runs in the office and found that it was much easier for the CRCs and physicians to enter data directly onto their iPad/laptop and hit "print" than to try to juggle a lot of paper to complete a study visit. Plus, this trial run proved that electronic form data was "cleaner" and easier to use when it came to data entry. We've talked to a few sponsors who didn't have an opinion either way and the FDA guidelines are vague when it comes to this. My understanding has always been that source is whatever it is - as you mentioned, source can be a Post-It note. Since most sponsors leave it up to the sites to create their source it really comes down - from what I've been told by sponsors - that whatever works best for us. I've been told by sponsors that "source" is a vague term and can be anything from a note that documents the visit as long as it clearly states the data points required for entry into EDC or it can be an elaborately created document with tables, check boxes and flowery verbiage that prompts the CRC to collect this or that. What are your takes on this?

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