| Template Name |
Version Number |
Version Date |
 Adult Consent Form Template |
Version 1.12 |
4/12/2024 |
| Parent Permission Form Template |
Version 1.13 |
4/12/2024 |
| Parent Consent and Permission Form Template |
Version 1.13 |
4/12/2024 |
| Parent Permission Exempt Information Sheet |
Version 1.4 |
8/9/2024 |
| Consent to Collect Data after Withdrawal Template |
Version 1.7 |
10/14/2022 |
| Brief Screening Agreement |
Version 1.4 |
8/9/2024 |
| Screening Questions Full Consent Template |
Version 1.7 |
4/14/2023 |
| Exempt Information Sheet Template |
Version 1.8 |
8/9/2024 |
| Adult Authorization Form Template – only use if consent form lacks authorization language |
Version 1.2 |
4/12/2024 |
| Single Patient Expanded Access Consent Template – only use for Individual Patient (drug or device) studies |
Version 1.0 |
7/14/2023 |
| Translator Qualifications Form |
Version 1.0 |
8/8/2018 |
| Recruitment Script Template |
Version 1.1 |
4/14/2023 |
 Instructions on Editing Signature Page for Existing Consent Forms |
Version 1.0 |
12/15/2016 |
| Protocol Template |
Version 1.5 |
8/9/2024 |
| Guidance for abbreviated IDE requirements |
Version 1.1 |
6/30/2016 |
| CAPA plan template |
Version 2 |
5/13/2022 |
| Opt-Out Recruitment Template |
Version 1.0 |
6/9/2023 |
| Guidance for Individual Patient IND and Emergency Use |
Version 1.0 |
8/30/2023 |