Folder and File Names
We have provided specific names for the folders (see Table 1) and subfolders of the submission as well as the table of contents files including the roadmap file. Using these names will minimize confusion among the Center's reviewers.
For file names not specifically described, we ask that you use the following naming conventions.
- Include the submission serial number for the file in the initial 4 numbers of the file.
- Use a descriptive name for the file up to a total of 28 characters. This is a total of 32 characters including the 4-digit serial number.
- Use the appropriate 3 - character extension for the file (e.g., pdf, xpt).
- Be consistent with the file names. For example, if you use the protocol number as part of the name of the original protocol, you should include the same name for the protocol revision.
For example, protocol 1234 provided in amendment number six could be named 0006_1234.pdf. The revised protocol submitted as part of amendment 125 would be named 0125_1234.pdf.
Bookmarks and Hypertext Links
For all documents with a table of contents, you should provide bookmarks and hypertext links for each item in the document's table of contents including all tables, figures, publications, and appendices even if included in a separate file, to serve as part of the table of contents for the submission.
To facilitate the review, you should provide hypertext links to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page throughout the body of the document. For a reference list at the end of a document, you should provide a hypertext link from the item listed to the appropriate PDF publication file. In order to provide reviewers maximal flexibility in using electronic documents, please avoid linking items across submission folders. We intend to review the information according to discipline and thus you should present your information in a modular fashion. For example, if you intend to use a reference to support a point in the CMC folder, you should not place the reference in the Clinical folder.
You should also include a bookmark to the roadmap, the submission's main table of contents, and the folder's table of contents at the highest level of the bookmark hierarchy for documents that you supplied as part of the submission.
Publications
You should provide each publication as a separate PDF file. Establish a hypertext link between the reference to the publication in the application and the publication. You should include the citation for the publication in the title portion of the Document Information field for each publication file.
Submission Management
Timely communications with the appropriate center and office staff prior to the submission of an electronic document are essential. You should contact us when questions arise.
You should notify us in writing of your intent to submit an electronic IND at least three months prior to the target arrival date for the application. Upon receipt and review of the written notification, our staff will schedule a teleconference to discuss the proposed electronic dossier. You should submit a CD-ROM, containing mock-up text and data, conveying your interpretation of the guidance for review by Center staff 45 days before the submission target date. As individual sponsors or product teams gaain experience in utilizing this submission type, we may find the CD-ROM demonstration to be unnecessary.
Because the review of an initial IND submission must be completed in 30 days, it is essential that the electronic IND submission function smoothly. The CD-ROM demonstration is a critical part of ensuring that smooth function. The CD-ROM demonstration should facilitate discussions of the planned regulatory submission through the presentations of mock-up text, tables, graphics, and data to CBER from the sponsor. The CD-ROM demonstration will: (1) present us with an opportunity to ensure that documents are presented in a standard format across all electronic IND applications; (2) present an opportunity for feedback from the review team on the presentation of regulatory information (e.g. dataset structures, hypertext links, bookmarking, and document quality); and (3) present an opportunity for our technical staff to provide feedback on how well the proposed submission structure is consistent with our guidance. Effective use of the demonstration and timely communication with our staff should enhance your understanding of this guidance document and its intent. We have listed the appropriate staff contacts for your submissions in Appendix C.
Application Structure
An IND is a compilation of many small submissions collected over an extended period of time. Frequently, during the review of an IND submission, a reviewer will need to refer to earlier submissions. To help reviewers navigate through the entire application, you should provide with each new submission a directory that includes a list of not only the files included in the current submission but all of the previously submitted files as well (See Appendix A - example roadmap.pdf file).
This list should be presented in reverse chronological order, by submission, as part of a PDF file called roadmap.pdf (see Appendix A). This file is linked to the submission's main table of contents, which is in turn linked to the table of contents provided in each subfolder. See section IV.E. below for additional details on the table of contents' files.