There is no “One Size fits all” SDEA, although they are generally similar. In fact, it`s friction. For large companies, any agreement can be a “single” agreement in which there are minor but real differences between the agreements. For example, you may need to send source documents to Company A after day 3 and CIOMS I after the 8th day. For Company B, day two or day 10; for C MedWatchs for U.S. cases and CIOMS I for ex-US cases on the 5th day for SUSARs and day 8 for all other SAEs, etc. In other words, each of them is so different that different procedures are needed for each partner. In large companies that receive more than 100,000 AEs/SAEs or more each year, and for dozens to hundreds of partners, this poses major business problems. The boiler platform should contain a brief paragraph indicating the reasons for the section`s presence (for the protection of public health and compliance with all regulatory and legal safety requirements), which is exchanged (see above: CIOMS I forms for SAE, source documents, etc.) when exchanged, aggregate reports, emergency situations (manipulations, market withdrawals, study stoppages, etc.). As a general rule, this boiler platform is not sufficient to cover all issues and a sentence should be added indicating that the parties will launch a formal and detailed written SDEA within 6 days of signing the contract. The “xx” depends on when patients are exposed to the product. A safety exchange mechanism must be put in place before a patient receives a drug.
Problems are common in that these agreements are concluded between companies in research, distribution or business development groups whose main objective is to initiate studies or sell more drugs. Drug safety (adverse reaction report) is rarely at the top of its list of priorities. In fact, they often don`t even think about it, or they realize at the last minute that they need a safe zone. I have often been at the difficult point of getting an email or an agreement with the indication that the CEO will sign tomorrow and “Is the safe zone OK” or “Please send us a security perimeter immediately”. The processing of security data varies somewhat between the United States, the EU and other areas, but, in general, the obligation to expedite security reports on suspected serious adverse events to the relevant authorities is similar, at least from areas. The period during which reports are to be received begins when the report is received by the third-party/subcontracting provider, NOT when the report reaches the MAH. It is therefore in the interest of the MAH that the reports be forwarded to them (or to the service provider) in order to obtain them as quickly as possible, so that they can be processed properly and on time. The DS/PV team should constantly inform the rest of the company of the presence of SDEAs in order to protect the company and public health. A written programming or procedural document must be signed at the highest level, which requires all divisions that may see security problems to have mechanisms for ADES and the obtaining and handling of security issues.