eCTD Submissions Q&A
Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD.
We received several great questions during a recent Introduction to eCTD webinar, but unfortunately did not have time to address all of them. Please find these questions and answers below.
Q: If a company is submitting its first eCTD, is it necessary that they first get some dummy file validated or checked by the US FDA and then submit the real dossier?
A: No. That said, if you are creating the submission by hand, then it would be a good idea to submit some dummy files first.
Q: What would you consider to be the best publishing and validation software?
A: We certainly feel that we have the best offering for publishing, validation, and review. Our VALIDATE and REVIEW products are the very tools used by the FDA, and so the need for quality is quite clear. PUBLISH has been built to be simple, intuitive, and easy to use, and is built on our solid foundation of VALIDATE and REVIEW
Q: Where can I get a copy of the ICH guidelines?
A: The current ICH eCTD specification, V3.2.2, can be found on the ICH website.
Q: How should SAE safety reports be submitted in eCTD and to which module are they submitted?
A: You should submit all serious adverse events through the FDA electronic submission gateway within the requisite time, preferably in ICSR format.
Q: What is the eCTD format for submitting Annual Report? Is there any guidance?
A: The FDA provides a submission type for submitting Annual Reports and an annual report is formatted in eCTD like all other submission types.
Q: When will the FDA no longer accept any submission in paper?
A: The FDA currently plans to mandate eCTD submissions in 2015.
Q: In MODULE 5 it is shown as ISS ISE, what exactly does it mean?
A: ISS and ISE stand for Integrated Summary of Safety and Integrated Summary of Efficacy, respectively. They would generally follow the same format as a clinical study and would be submitted in.
Q: What is the file type we use for checksum?
A: Checksums are generally stored as an attribute in the backbone and regional XML files, with the exception of the checksum for the backbone itself, which will be a text file in the root directory of the submission at the same level as the backbone XML file.MD5 is the checksum attribute that is used.
Q: Do we have any standard template for NDA and IND submissions to FDA?
A: The FDA has Application Types for NDAs and INDs, with guidelines for each type.
Q: Can we submit both non clinical (module 4) and clinical trials (module 5) at once? If so, in which application type can we submit?
A: Yes, both clinical and non-clinical data can be submitted in the same sequence. The application type would be unrelated to this, and instead would be based on what type of application you intend to submit (e.g. NDA, ANDA, IND, etc.). The Submission Type would also depend on what stage of the application you are in, and what you’re submitting for (i.e. Original Application if you are on your initial sequence, Amendment if you are adding data to an existing sequence, or a Supplement if you are adding additional parameters to your application.
Q: In the study tagging file specification we go through new/append/replace/delete. In what circumstances is it shown and how it is used? It is mentioned as same name as the study, I just want to know whether it is study id or study title?
A: The study Id is the key identifier of the study tagging file. The operation (i.e. new, append, replace,and delete) will be located in the index.xml not the study tagging file.
Q: What is the difference between the publisher and author of application?
A: An author is a person who is actually writing the documents themselves, compiling the document in Word or a similar tool. A publisher is a person who takes these finished documents and places them correctly in the structure of the eCTD and generates the XML and associated required files.
Q: When lifecycling Annual Reports section 1.13, should these be done as NEW every reporting period or should a new reporting period REPLACE the previous year’s reporting period?
A: No. Annual Reports would be something you would want to persist. The best way to think of this is that when you are replacing a file, you are saying that the information and content of that document are no longer relevant and you are submitting a replacement for that data. Annual Reports represent cyclically collected data and would be something you would want to retain throughout the progression of your application.
Q: What are the eCTD requirement dates for: CDRH, CBER, EU?
A: The FDA currently plans to mandate eCTD submissions in 2015, while the EMA and CDRH has not announced any plans to mandate electronic submissions.
Q: How do you select the right electronic publishing software for eCTD?
A: We believe you should select publish software that eases your process, allows for greater productivity, and produces quality output.
Q: Some word files are also used in the submission, how we will ensure its integrity after submission?
A: The integrity of the data can be checked at any later time by recomputing the checksum and comparing it with the stored one checksum in the submission. If the checksums match, the data is not altered.