Insights Blog

Q&A Follow-up from “What ICH E6(R2) Really Means for Research Sites!”

Posted on Nov 13, 2018 2:05:02 PM

Polaris Compliance Consultants was delighted to present Complion’s October 24th webinar, “What ICH E6(R2) Really Means for Research Sites!” Far more questions were submitted during the webinar than we could address during the Q&A period, so we would like to answer them here. It was interesting to see that most of the questions related to documentation and document retention. That can be a confusing area for study sites. We hope you find these responses helpful.

Please note: Click here to review the full list of questions submitted. Due to the quantity and content of questions received, responses have been concatenated for brevity. 

Document Retention

  • ICH E6(R2) states the following: “Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product.” If a longer record retention is required by regulation that must be followed.
    • Note that this does not provide a definitive timeline for record retention.
    • Because Canada requires retention for at least 25 years from the date of creation, and data could be submitted to Health Canada, we recommend that sites plan to retain for 25 years.
    • Some participants expressed concern over the cost of retention. Sites should consider the cost when planning to conduct research and negotiating budgets with sponsors. Many sites include the cost of record retention in their study budgets as a line item; some include it in the overhead payment.
  • ICH E6(R2) applies to all trials that include human participation, regardless of whether or not the trial is for drugs or devices.
  • Although it is the sponsor’s responsibility to notify investigators when study records may be destroyed, the Principal Investigator (PI) is responsible for document retention for the required retention period (see more on this below), and this supersedes instructions from a sponsor.
  • If the sponsor company no longer exists, and the retention period has passed, the records can be destroyed. If the PI is unsure if the retention period has passed, there are a number of options:
  1. Contact the company that acquired the original sponsor, if any. The new sponsor that acquired the rights to the data (and typically assumed responsibility or existing contracts) may request to inspect the records;
  2. Contact the current manufacturer/sponsor of the investigational product; or
  3. Contact the FDA.
  • Site Regulatory Binders could be scanned and saved on a long-term storage medium (such as a CD), provided there is a written procedure in place for making and certifying copies, and the medium could not be altered thereafter.
  • If an institution purges records after a certain period of time that is less than the required record retention period, the investigator must ensure that all study-related records are retained, including x-ray images. This is especially important if the record is for a study-required evaluation. If the document/record is not for a study-required evaluation, then retaining only the report would be sufficient.
  • “Shadow” files were common prior to ICH. They do not meet Good Documentation Standards and are not recommended.

Allowing Access to Complete Records

  • Monitors, auditors, and inspectors need access to complete trial site records for the trial duration. Adverse events have been found to be recorded on progress notes, rehabilitation records, x-ray technician notes, etc.
  • Printing records from the sites Electronic Medical Record (EMR) does not allow a monitor, auditor, or inspector to ensure that the record they received is complete. At least periodic access should be allowed. Some sponsors will not work with sites that do not allow access to original records. One option is to use paper source records for clinical trials.
  • If information is printed from the Electronic Medical Record, it should be dated/initialed as being an exact copy of the original, regardless of whether or not it contains a system generated date stamp.
  • With the current environment of Sponsor or CRO buy-outs or consolidation, the Sponsor or CRO that a site begins working with may change as the study progresses. In these cases the site must allow the new Sponsor/CRO to review data, even if the study is closed.


  • If a question on a consent form does not apply to a subject, and it is not clear how this should be addressed, e.g., by having a “Not applicable” option, the site should get written instruction from the IRB/IEC that confirms how to handle this.
  • There is no requirement to have a place for the subject to initial and date each page of an informed consent form. If there is a place to do this, then it must be completed. Adding unnecessary steps makes the process more burdensome to the subject and increases the risk of non-compliance. It does not provide any extra proof that the subject read or understood the form. The subject’s dated signature at the end of the form serves that purpose.
  • There is often blank space at the end of an informed consent form. There is no regulatory prohibition from writing notes in this space, provided the notes do not interfere with or change the content of the consent. It is not a common or recommended practice, but it is not a regulatory violation.


  • Records should be current. This includes updating concomitant medication lists regardless of the frequency of changes and number of medications.
  • There are three main types of electronic records used by sites for clinical trials, with multiple options for each type of system (Polaris Compliance Consultants does not endorse any one brand):
    • The site’s EMR
    • Electronic Case Report Form (eCRF) system provided by the sponsor or CRO
    • Electronic Source (eSource) system, which is also provided by the sponsor or CRO
  • Reading and knowing ICH E6(R2) is the best way to know its requirements. Additional training is offered at seminars, and online from multiple sources.
  • If copies of records will be uploaded to sponsor/CRO-provided eSource (e.g., hospital records documenting a serious adverse event, or non-study visit records), the subject’s information should be de-identified so that their personal information is not provided to the sponsor/CRO.

Thank you all for your engagement with this webinar. That’s what keeps it interesting!

Topics: Compliance, Regulatory Compliance, Document Management, GCP

Mary McGuire, GCP Auditor on Behalf of Polaris Consultants

Written by Mary McGuire, GCP Auditor on Behalf of Polaris Consultants

Mary McGuire is a GCP Quality Assurance specialist, trainer, auditor, and project manager, authoring on behalf of Polaris Compliance Consultants. She is an R.N. with extensive clinical and pharmaceutical experience, and understands both sponsor and investigative site needs. She has over twenty years of experience in Quality Assurance.

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