Frequently Asked Questions: Documents to Pull

Resources: For Accreditation - FAQs

Documents to Pull FAQs

When will my organization receive the list of documents to pull?

You will receive the list of Documents to Pull no later than six weeks before the site visit.

When should my organization have all documents available and accessible to site visitors?

All Documents to Pull must be uploaded and accessible to site visitors 15 calendar days prior to the site visit. This requirement is to make sure that our site visitors have adequate time to review your documents and assess your HRPP.

Note: Provide site visitors with any necessary logins, passwords, links, and instructions for how they will access the Documents to Pull as soon as possible. This will allow the site visitors an opportunity to confirm access to the electronic system(s) and to troubleshoot (and fix) any IT issues related to electronic system(s) prior to the start of the review period. We suggest that you also create a backup plan in case there are problems with site visitors accessing the electronic system(s).

A minimum of 15 calendar days before the first day of the site visit: Pre-site visit meeting occurs, and the organization provides a virtual tour of the system(s) to be used for reviewing the Documents to Pull. Please have tech support available during the pre-site visit meeting and throughout the duration of the site visit to assist in troubleshooting any issues that may arise.

How many years should we go back when pulling documents?

AAHRPP expects organizations to provide the most recent versions of documents. However, in some cases, the type of document AAHRPP asks to be provided may be something your organization does not commonly encounter. Please wait until you receive the list of Documents to Pull from AAHRPP to ensure that you pull only the documents that AAHRPP requires for your site visit.

If you are applying for initial accreditation, provide the most recent documents per the instructions in the Documents to Pull provided to your organization. “Most recent documents” means those in the last two years. If the “most recent document” is older than two years, then you do not need to provide it. For example, for studies, provide the most recent study initially approved in the last two years.
If you are applying for reaccreditation, provide the most recent documents per the instructions in the Documents to Pull provided to your organization. “Most recent documents” means those since your last site visit. If the “most recent document” is older than the prior site visit, then you do not need to provide it. For example, for studies, provide the most recent study initially approved since your last site visit.

Can one study satisfy multiple criteria? The table in the Documents to Pull asks for different types of studies (e.g., an industry-sponsored study with an IND, a study involving children).

Yes. For example, you could list the same study under different criteria per IRB/EC (or IRB/EC panel):

A drug study that involves children and pregnant women could be listed under the drugs category, the children category, and the pregnant women category.
A study that underwent expedited review and the IRB granted a waiver of informed consent could be listed under the expedited review category and the waiver of consent category.

Our organization’s IRBs/ECs do not review certain types of research, but AAHRPP asks for documents about research they do not review. What should we do?

If your organization does not conduct or review certain research (for example, research involving prisoners), indicate “not applicable” (e.g., in chart from AAHRPP; in the name of an electronic file folder).

Our IRB/EC records are in an electronic system. Do we have to provide site visitors access to that system to conduct document review?

The purpose of the site visit is to evaluate how your HRPP functions in practice. Providing access to your online system allows site visitors to fully evaluate your program. If your organization cannot provide site visitors with direct access to the electronic system that contains IRB/EC records (for example, if your system is not in English), you may provide records in another way (e.g., an online document storage system or platform, such as Dropbox, Box, or Google Drive). However, you must provide all the same records that are in your IRB/EC management system (including but not limited to complete study files, reviewer comment forms, minutes, and all other records required by regulations and AAHRPP).

How do I provide documents if some or all are paper files?

You will need to make electronic copies of the documents and make them accessible through a cloud-based platform, such as Dropbox, Box, or Google Drive. Please ensure that the files are searchable (OCR-enabled).

What is a “complete protocol”/“complete study”?

This refers to all information required by regulations, including continuing review and modifications.

See the definition of “complete protocol” in the Evaluation Instrument, Element II.5.A. for a list of the documents included in a complete protocol or study.

Also provide relevant portions of minutes for all convened IRB/EC actions related to the study. (Element II.5.B.)

Does AAHRPP have recommendations about how to organize the studies requested in the Documents to Pull?

You will receive instructions about best practices to organize records with the request for documents to pull.

My organization’s documents are not in English; which documents do we need to translate and provide?

You will receive instructions about what records must be translated with the request for documents to pull.

What if my organization does not have any studies?

Contact AAHRPP to inform us at [email protected] and [email protected].

Resources: For Accreditation - FAQs