**DMID Language and Translation Requirements Summary**

**Essential Document Requirements and Instructions (Appendix B)**

*This chart is a summary/worksheet of the requirements for translation
for essential documents.* *The responsibility for translation lies with
the contract or grant. This chart may also be used as a worksheet. The
first column with boxes indicates documents which must be translated and
submitted to DMID before the study can start.*

+---+---------------+--------+-----------+----------------------------+
|   |               | LA     |           |                            |
|   |               | NGUAGE |           |                            |
|   |               | REQUI  |           |                            |
|   |               | REMENT |           |                            |
+===+===============+========+===========+============================+
|   | DOCUMENT      | E      | LANGUAGE  | ADDITIONAL COMMENTS AND    |
|   |               | NGLISH | FAMILIAR  | INSTRUCTIONS               |
|   |               |        | TO LOCAL  |                            |
|   |               |        | SITE      |                            |
+---+---------------+--------+-----------+----------------------------+
|   | FINAL         | *      | **YES**   | The protocol may be in     |
|   | PROTOCOL      | *YES** |           | English if English is      |
|   |               |        |           | understood by the key      |
|   |               |        |           | local staff. If the key    |
|   |               |        |           | local staff, other than    |
|   |               |        |           | the PI, do not understand  |
|   |               |        |           | English, specific          |
|   |               |        |           | operational sections of    |
|   |               |        |           | the protocol may be        |
|   |               |        |           | required to be translated  |
|   |               |        |           | to support accurate        |
|   |               |        |           | protocol implementation .  |
|   |               |        |           | Determinations of specific |
|   |               |        |           | sections will be made      |
|   |               |        |           | between the DMID Branch    |
|   |               |        |           | and OCRA                   |
+---+---------------+--------+-----------+----------------------------+
|   | PROTOCOL      | *      | **YES**   | See comment for Final      |
|   | REVISIONS     | *YES** |           | Protocol                   |
+---+---------------+--------+-----------+----------------------------+
|   | INFORMED      | *      | **YES**   | Informed Consent Forms     |
|   | CONSENT       | *YES** |           | must be in a language      |
|   |               |        |           | familiar to study          |
|   |               |        |           | participants. For further  |
|   |               |        |           | guidance on informed       |
|   |               |        |           | consent regulations see    |
|   |               |        |           | [45 CFR                    |
|   |               |        |           | 46.116](http://www.hhs.gov |
|   |               |        |           | /ohrp/humansubjects/guidan |
|   |               |        |           | ce/45cfr46.htm#46.116 21), |
|   |               |        |           | (http://www.hh             |
|   |               |        |           | s.gov/ohrp/humansubjects/g |
|   |               |        |           | uidance/45cfr46.htm#46.116 |
|   |               |        |           | 21) and [CFR               |
|   |               |        |           | 50.20](h                   |
|   |               |        |           | ttp://www.accessdata.fda.g |
|   |               |        |           | ov/scripts/cdrh/cfdocs/cfC |
|   |               |        |           | FR/CFRSearch.cfm?fr=50.20) |
|   |               |        |           | (<ht                       |
|   |               |        |           | tp://www.accessdata.fda.go |
|   |               |        |           | v/scripts/cdrh/cfdocs/cfCF |
|   |               |        |           | R/CFRSearch.cfm?fr=50.20>) |
|   |               |        |           |                            |
|   |               |        |           | **FOR NON-U.S.             |
|   |               |        |           | SITES****-** If the        |
|   |               |        |           | original document was      |
|   |               |        |           | written in English and     |
|   |               |        |           | participants do not speak  |
|   |               |        |           | English, once translated,  |
|   |               |        |           | it must be back translated |
|   |               |        |           | from the local language to |
|   |               |        |           | English.                   |
|   |               |        |           |                            |
|   |               |        |           | -If the original document  |
|   |               |        |           | was written in a language  |
|   |               |        |           | other than English it must |
|   |               |        |           | be translated into English |
|   |               |        |           | and submitted with the     |
|   |               |        |           | DMID Translation           |
|   |               |        |           | Equivalence Form.          |
|   |               |        |           |                            |
|   |               |        |           | **FOR U.S SITES**-If the   |
|   |               |        |           | performance site(s) are in |
|   |               |        |           | the U.S. using non-English |
|   |               |        |           | documents, the DMID will   |
|   |               |        |           | accept the [DMID           |
|   |               |        |           | Translation Equivalence    |
|   |               |        |           | Form                       |
|   |               |        |           | .](#DMID_Trans_Equiv_form) |
+---+---------------+--------+-----------+----------------------------+
|   | Standard      | **SEE  | **YES**   | A list in English of SOPs  |
|   | Operating     | COMM   |           | should be provided. A      |
|   | Procedures    | ENTS** |           | decision between the DMID  |
|   | (SOPs)        |        |           | Branch and OCRA will be    |
|   | (S            |        |           | made about which SOPs need |
|   | ite-specific) |        |           | translating. This          |
|   |               |        |           | translation may depend on  |
|   |               |        |           | the language of the        |
|   |               |        |           | monitor and the            |
|   |               |        |           | information on which DMID  |
|   |               |        |           | needs verification (i.e.,  |
|   |               |        |           | product handling or        |
|   |               |        |           | specifics on an invasive   |
|   |               |        |           | procedure that is not      |
|   |               |        |           | covered in the protocol.   |
+---+---------------+--------+-----------+----------------------------+
|   | Manual of     | **SEE  | **YES**   | A list in English of MOP   |
|   | Procedures    | COMM   |           | procedures should be       |
|   | (MOP) per     | ENTS** |           | provided. A decision       |
|   | Protocol      |        |           | between the DMID Branch    |
|   |               |        |           | and OCRA will be made      |
|   |               |        |           | about which procedures     |
|   |               |        |           | need translating. This     |
|   |               |        |           | translation may depend on  |
|   |               |        |           | the language of the        |
|   |               |        |           | monitor and the            |
|   |               |        |           | information on which DMID  |
|   |               |        |           | needs verification (i.e.,  |
|   |               |        |           | product handling or        |
|   |               |        |           | specifics on an invasive   |
|   |               |        |           | procedure that is not      |
|   |               |        |           | covered in the protocol.   |
+---+---------------+--------+-----------+----------------------------+
|   | Investigator  | *      | **N/A**   | IB language is English as  |
|   | Brochure      | *YES** |           | required by IND            |
|   |               |        |           | application regulations 21 |
|   |               |        |           | CFR 312. **Contact the     |
|   |               |        |           | DMID Clinical Project      |
|   |               |        |           | Manager.**                 |
+---+---------------+--------+-----------+----------------------------+
|   | A             | *      | **YES**   | See informed consent       |
|   | dvertisements | *YES** |           | comments                   |
|   | and Other     |        |           |                            |
|   | Information   |        |           |                            |
|   | given to      |        |           |                            |
|   | participants  |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | IRB/IEC       | *      | **N/A**   | Document must be           |
|   | Approval of:\ | *YES** |           | translated and accompanied |
|   | -Final        |        |           | by [DMID Translation       |
|   | Protocol\     |        |           | Equivalence                |
|   | -Informed     |        |           | Form                       |
|   | Consent\      |        |           | .](#DMID_Trans_Equiv_form) |
|   | -Protocol     |        |           |                            |
|   | Amendment(s)\ |        |           |                            |
|   | -Ann          |        |           |                            |
|   | ual/Bi-Annual |        |           |                            |
|   | study         |        |           |                            |
|   | approval\     |        |           |                            |
|   | -Information  |        |           |                            |
|   | given to      |        |           |                            |
|   | Trial         |        |           |                            |
|   | subjects\     |        |           |                            |
|   | -Advertisemen |        |           |                            |
|   | t/Recruitment |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | [FDA Form     | *      | **N/A**   | The 1572 is required for   |
|   | 1             | *YES** |           | all studies under IND. The |
|   | 572](http://w |        |           | IOR form is for non-IND    |
|   | ww.fda.gov/op | *      |           | studies and the DMID form  |
|   | acom/morechoi | *YES** |           | should be used             |
|   | ces/fdaforms/ |        |           |                            |
|   | FDA-1572.pdf) |        |           |                            |
|   | (for IND      |        |           |                            |
|   | studies) or   |        |           |                            |
|   |               |        |           |                            |
|   | Investigator  |        |           |                            |
|   | of Record     |        |           |                            |
|   | Form (IOR)    |        |           |                            |
|   | for non-IND   |        |           |                            |
|   | studies       |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | Foreign       | *      | **N/A**   | Document must be           |
|   | regulato      | *YES** |           | translated and accompanied |
|   | ry/government |        |           | by a signed equivalence    |
|   | approval and  |        |           | statement. Use the [DMID   |
|   | other agency  |        |           | Translation Equivalence    |
|   | approval (If  |        |           | For                        |
|   | applicable)   |        |           | m](#DMID_Trans_Equiv_form) |
+---+---------------+--------+-----------+----------------------------+

**Requirements for Essential Documents for DMID Interventional Studies
(involving study/investigational product)**

Note: If the clinical research does not involve a study/investigational
product, those related essential documents will be not required.

+---+---------------+--------+-----------+----------------------------+
|   |               | LA     |           |                            |
|   |               | NGUAGE |           |                            |
|   |               | REQUI  |           |                            |
|   |               | REMENT |           |                            |
+===+===============+========+===========+============================+
|   | DOCUMENT      | E      | LANGUAGE  | ADDITIONAL COMMENTS AND    |
|   |               | NGLISH | FAMILIAR  | INSTRUCTIONS               |
|   |               |        | TO LOCAL  |                            |
|   |               |        | SITE      |                            |
+---+---------------+--------+-----------+----------------------------+
|   | SAE Reports   | *      |           | [DMID SAE reporting        |
|   | to DMID       | *YES** |           | form](http://www3.nia      |
|   |               |        |           | id.nih.gov/research/resour |
|   |               |        |           | ces/DMIDClinRsrch/SAE.htm) |
|   |               |        |           | should be used             |
+---+---------------+--------+-----------+----------------------------+
|   | SAE Report    | *      |           |                            |
|   | Supporting    | *YES** |           |                            |
|   | Documentation |        |           |                            |
|   | To DMID       |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | [FDA Form     | *      |           | The 1572 is required for   |
|   | 1             | *YES** |           | all studies under IND. The |
|   | 572](http://w |        |           | IOR form is for non-IND    |
|   | ww.fda.gov/op |        |           | studies and the DMID form  |
|   | acom/morechoi |        |           | should be used             |
|   | ces/fdaforms/ |        |           |                            |
|   | FDA-1572.pdf) |        |           |                            |
|   | (for IND      |        |           |                            |
|   | studies) or   |        |           |                            |
|   | Investigator  |        |           |                            |
|   | of Record     |        |           |                            |
|   | Form (IOR)    |        |           |                            |
|   | non-IND       |        |           |                            |
|   | studies       |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | Data          | **See  | **YES**   | Language used must be one  |
|   | Collection    | Comm   |           | the local staff filing in  |
|   | Tools         | ents** |           | the forms understands.     |
|   |               |        |           |                            |
|   |               |        |           | Program may want all or    |
|   |               |        |           | specific forms translated  |
+---+---------------+--------+-----------+----------------------------+
|   | Principal     | **See  |           | The credentials of the     |
|   | Investigator  | Comm   |           | investigator must be       |
|   | CV/Biosketch  | ents** |           | translated for             |
|   |               |        |           | interventional and         |
|   |               |        |           | invasive studies, but it   |
|   |               |        |           | is not necessary to        |
|   |               |        |           | translate publication      |
|   |               |        |           | citations. For other       |
|   |               |        |           | studies DMID may need to   |
|   |               |        |           | verify their credentials   |
|   |               |        |           | through translation        |
+---+---------------+--------+-----------+----------------------------+
|   | Sub           | **See  |           | The credentials for        |
|   | -Investigator | Comm   |           | sub-investigator must be   |
|   | CV/Biosketch  | ents** |           | translated for IND must be |
|   |               |        |           | translated, but it is not  |
|   |               |        |           | necessary to translate     |
|   |               |        |           | publication citations. For |
|   |               |        |           | non-IND studies DMID may   |
|   |               |        |           | need to verify their       |
|   |               |        |           | credentials through        |
|   |               |        |           | translation.               |
+---+---------------+--------+-----------+----------------------------+
|   | DMID          | *      |           | Required for IND studies   |
|   | Financial     | *YES** |           | only                       |
|   | Disclosure    |        |           |                            |
|   | Form          |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | In            | *      | **YES**   | Document must be           |
|   | vestigational | *YES** |           | translated into            |
|   | Product label |        |           | appropriate language and   |
|   |               |        |           | accompanied by a signed    |
|   | (if           |        |           | equivalence statement.     |
|   | applicable)   |        |           | Please use the [DMID       |
|   |               |        |           | Translation Equivalence    |
|   |               |        |           | Form                       |
|   |               |        |           | ](#DMID_Trans_Equiv_form). |
+---+---------------+--------+-----------+----------------------------+
|   | Shipping      |        | **YES**   |                            |
|   | Records for   |        |           |                            |
|   | In            |        |           |                            |
|   | vestigational |        |           |                            |
|   | Product and   |        |           |                            |
|   | Trial-Related |        |           |                            |
|   | Materials     |        |           |                            |
+---+---------------+--------+-----------+----------------------------+
|   | In            | **See  |           | Shells/ templates for the  |
|   | vestigational | comm   |           | test article               |
|   | Product       | ents** |           | accountability logs must   |
|   | A             |        |           | be translated if the study |
|   | ccountability |        |           | is to be monitored in      |
|   | Logs (if      |        |           | English.                   |
|   | applicable)   |        |           |                            |
|   |               |        |           | Documents that must be     |
|   |               |        |           | translated should be       |
|   |               |        |           | accompanied by a signed    |
|   |               |        |           | [DMID Translation          |
|   |               |        |           | Equivalence                |
|   |               |        |           | For                        |
|   |               |        |           | m](#DMID_Trans_Equiv_form) |
+---+---------------+--------+-----------+----------------------------+
|   | Lab Normal    |        | **YES**   | Site may submit documents  |
|   | Value(s) or   |        |           | in available language/     |
|   | Range(s) for  |        |           | language issued. NOTE: If  |
|   | medical,      |        |           | lab values are not         |
|   | technical, or |        |           | provided in the Latin      |
|   | laboratory    |        |           | alphabet, translation will |
|   | tests and     |        |           | be required using the      |
|   | procedures    |        |           | [DMID Translation          |
|   |               |        |           | Equivalence                |
|   |               |        |           | Form                       |
|   |               |        |           | ](#DMID_Trans_Equiv_form). |
+---+---------------+--------+-----------+----------------------------+
|   | Laboratory    |        | **YES**   | Site may submit documents  |
|   | Cer           |        |           | in available language/     |
|   | tifications/Q |        |           | language issued.           |
|   | ualifications |        |           |                            |
|   | for           |        |           |                            |
|   | procedures    |        |           |                            |
|   | and tests     |        |           |                            |
+---+---------------+--------+-----------+----------------------------+